# K063375: Heartstart MRX, Models M3535A or M3536A

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jan 11, 2007 after 64 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011865 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 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 1.
- K051134: Heartstart MRX with Q-CPR Option, Models M3535A or M3536A, Philips Medical Systems (2005) Summary page 1.
- K061707: Heartstart MRX, Invasive Pressure & Temperature Options, Philips Medical Systems (2006) Summary page 1.

## Recalls of this device
- Apr 10, 2020 · Class II · Z-2064-2020: Damaged ESD bags used for storing components in Processor PCA Replacement Kits
- Feb 26, 2020 · Class II · Z-1499-2020: Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a se
- Jan 14, 2020 · Class II · Z-1342-2020: M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
- Jul 16, 2019 · Class II · Z-2488-2019: Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
- Jun 7, 2019 · Class II · Z-1923-2019: The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring
- May 3, 2018 · Class II · Z-2035-2018: The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause the
- 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).
- 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.
- 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-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. 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 NBP option is intended for non-invasive measurement of a patient's arterial blood pressure. End-tidal C02 The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. 12-Lead ECG The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. Q-CPR The Q-CPRT M 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/K063375
Methodology: https://510kreport.com/methodology