# K051134: Heartstart MRX with Q-CPR Option, Models M3535A or M3536A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 8, 2005 after 128 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 39 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 6 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Philips Medical Systems HeartStart MRx monitor/defibrillator: named in the summary without a submission number
- (no number) ZOLL Medical Corp. Zoll AED Plus with CPR-D Padz external defibrillator: named in the summary without a submission number

## Most influential descendants
- K122050: Cprmeter CPR Feedback Device (2012), 5 descendants of its own
- K061707: Heartstart MRX, Invasive Pressure & Temperature Options (2006), 4 descendants of its own
- K151702: Reusable Full Silicone Cover (2015), 3 descendants of its own
- K173886: CPRmeter 2 CPR Feedback Device (2018), 2 descendants of its own
- K130153: Hearstart MRX with Airway Confimration Assist (2013), 2 descendants of its own

## Recalls of this device
- Apr 27, 2020 · Class II · Z-2157-2020: HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
- Nov 23, 2018 · Class II · Z-0603-2019: Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, w
- Jan 29, 2018 · Class II · Z-0684-2018: Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent In
- Sep 28, 2017 · Class II · Z-0278-2018: Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).
- Jul 17, 2017 · Class II · Z-0348-2018: Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/d
- Jul 12, 2017 · Class I · Z-0489-2018: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks i
- Feb 24, 2017 · Class I · Z-1417-2017: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
- Aug 26, 2016 · Class II · Z-2842-2016: The handle can separate from the MRx housing due to breakage of mounts on the rear case.
- Apr 14, 2016 · Class II · Z-1612-2016: MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
- Oct 14, 2015 · Class II · Z-0320-2016: The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use
- Dec 23, 2014 · Class II · Z-0219-2016: MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed
- Nov 19, 2014 · Class II · Z-0204-2016: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installe
- Nov 19, 2014 · Class II · Z-0273-2016: When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from e
- Nov 19, 2014 · Class II · Z-0262-2016: MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, 
- Nov 19, 2014 · Class II · Z-0963-2015: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
- Feb 18, 2014 · Class II · Z-1108-2014: Wireless Link may be unable to transmit data when configured for a specific data flow.
- Feb 18, 2014 · Class II · Z-1120-2014: Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy s
- Feb 18, 2014 · Class II · Z-1090-2014: A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.
- Feb 18, 2014 · Class II · Z-1118-2014: ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
- Feb 18, 2014 · Class II · Z-1194-2014: When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
- Feb 14, 2014 · Class II · Z-1109-2014: Philips HeartStart XL may experience a power board failure causing failure to defibrillate
- Feb 4, 2014 · Class II · Z-1110-2014: HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
- Dec 10, 2013 · Class II · Z-0570-2014: MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
- Jun 19, 2013 · Class II · Z-1797-2013: The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation.
- Jun 7, 2013 · Class II · Z-0593-2014: Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10
- Apr 10, 2013 · Class II · Z-0613-2014: Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
- Apr 8, 2013 · Class II · Z-1189-2013: Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
- Jun 20, 2012 · Class II · Z-1896-2012: HeartStart MRx Unexpected Pads/Paddles ECG Failure
- Jun 20, 2012 · Class II · Z-1986-2012: Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
- Jun 20, 2012 · Class II · Z-2347-2012: Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
- Feb 7, 2011 · Not classified · Z-1609-2011: Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.
- May 6, 2010 · Not classified · Z-2293-2010: Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplet
- Apr 7, 2010 · Not classified · Z-1618-2010: ECG signal processing chip may fail causing failure to deliver therapy in AED mode or the failure to indicate poor electrical contact (very high impedance) with the patient in Manual Defib mode.
- Mar 4, 2010 · Not classified · Z-1317-2010: Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on batter
- Nov 19, 2009 · Not classified · Z-1260-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1259-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1257-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1258-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 12, 2009 · Not classified · Z-0562-2010: HeartStart Vehicle Wall Mount (Model M5528A) with DC Power Module (Model M5529A)--Incorrect wiring during installation by user may result in a smoke or fire hazard.

## Indications for use
The HeartStart MRx monitor/defibrillator with Q-CPR™ option is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. AED Therapy To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless. Manual Defibrillation Therapy Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized defibrillation is indicated for termination of atrial fibrillation. Non-Invasive External Pacing Therapy The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early. Pulse Oximetry The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level. Non-Invasive Blood Pressure Monitoring The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure. Endtidal CO2 Monitoring The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. 12-Lead ECG The 12-Lead ECG option is intended to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. Q-CPR The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time). The Q-CPR option is contraindicated as follows: * The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). * The Q-CPR option is not for use when CPR is contraindicated.

Source page: https://510kreport.com/device/K051134
Methodology: https://510kreport.com/methodology