# K061707: Heartstart MRX, Invasive Pressure & Temperature Options

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems
- Decided: Aug 11, 2006 after 56 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 12 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011865 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031187: Heartstart MRX, Model M3535A, Philips Medical Systems (2003) Summary page 2.
- K051134: Heartstart MRX with Q-CPR Option, Models M3535A or M3536A, Philips Medical Systems (2005) Summary page 2.
- K011865: Zoll M Series Ibp Operation; Zoll M Series Temperature Option, Zoll Medical Corp (2001)

## Most influential descendants
- K130153: Hearstart MRX with Airway Confimration Assist (2013), 2 descendants of its own
- K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring (2015), 1 descendant of its own
- K200849: Tempus LS - Manual (2020), 0 descendants of its own
- K063375: Heartstart MRX, Models M3535A or M3536A (2007), 0 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The HeartStart MRx 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 Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation. Noninvasive 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. Noninvasive Blood Pressure Monitoring The NBP option is intended for noninvasive measurement of a patient's arterial blood pressure. End-tidal C02 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 function isto provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. Q-CPR The Q-CPR TM 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 that 25 kg). The Q-CPR option is not for use when CPR is contraindicated. Invasive Pressure The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients. Temperature The Temperature option is indicated for measuring temperature in patients.

Source page: https://510kreport.com/device/K061707
Methodology: https://510kreport.com/methodology