# K040404: Heartstart MRX, Model M3535A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: May 4, 2004 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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) ZOLL Medical Corp., PowerBase TM: named in the summary without a submission number
- (no number) Medtronic Physio-Control Battery Support System 2: named in the summary without a submission number

## 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 Cadex Battery-Charger for Philips HeartStart Batteries is used to recharge and analyze rechargeable batteries that are used with Philips HeartStart manual defibrillator/monitors.

Source page: https://510kreport.com/device/K040404
Methodology: https://510kreport.com/methodology