# K031187: Heartstart MRX, Model M3535A

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems
- Decided: Aug 27, 2003 after 134 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 21 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 4 cite it directly.
3 of 45 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 (formally Agilent Technologies) Heartstream XL Defibrillator/Monitor: named in the summary without a submission number
- (no number) ZOLL Medical Corp. M Series Defibrillator: named in the summary without a submission number

## Most influential descendants
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model (2010), 37 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own

## Recalls of this device
- Sep 14, 2020 · Class II · Z-0284-2021: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has c
- Sep 14, 2020 · Class II · Z-0285-2021: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has c
- Jul 16, 2020 · Class II · Z-2794-2020: The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selecte
- 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.
- Jan 19, 2010 · Not classified · Z-1135-2010: Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy
- Aug 21, 2009 · Not classified · Z-0003-2010: incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC o
- Jul 7, 2009 · Not classified · Z-1795-2009: External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/CPR cable and the MRx/MRxE may wear at an increased rate ultimately prevent the 
- Jul 14, 2008 · Not classified · Z-2337-2008: Defective internal memory cards may exhibit one or more of the following behaviors: "Device repeatedly restarts approximately every 20 seconds "Slow device start-up of approximately 15 seconds or more
- Apr 29, 2005 · Not classified · Z-0848-05: The device may disarm and not deliver shock when performing a Synchronized Cardioversion
- Dec 15, 2004 · Not classified · Z-0341-05: In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy

## Indications for use
The HeartStart M R x 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. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillatorhlonitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 15oJ. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications. Manual Defibrillation: 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. 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. Non-Invasive External Pacing: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early. 12-Lead ECG: The 12-Lead ECG option is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms. Non-Invasive Blood Pressure: The NlBP option is intended for noninvasive measurement of arterial blood pressure for adult and pediatric patients. Endtidal COz: The EtC02 option is intended for noninvasive monitoring of exhaled carbon dioxide and to provide a respiration rate for adult, pediatric and neonatal patients. Pulse Oximetry: The SpOz option is intended for use when it is beneficial to assess the oxygen saturation level for adult and pediatric patients.

Source page: https://510kreport.com/device/K031187
Methodology: https://510kreport.com/methodology