HeartStart MRx Lithium Ion Battery ModuleRecalls & reported problems

Philips Medical Systems Hsg · Lithium Ion Battery Module · Class 3

All models of HeartStart (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 12
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884838002791), received between Oct 14, 2019 and Oct 4, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (12 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Nov 23, 2018Class IITerminated
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, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
Z-0603-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

Battery Problem12
Failure of Device to Self-Test1
Failure to Charge1

Patient problems

No Clinical Signs, Symptoms or Conditions11
No Patient Involvement1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 4, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12569038 ↗
MalfunctionOct 4, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12568805 ↗
MalfunctionAug 31, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY MALFUNCTIONED. THE CUSTOMER WORKED WITH THE TECHNICAL SUPPORT REPRESENTATIVE. THE CUSTOMER CONFIRMED THE NEED FOR A BATTERY EXCHANGE. THE REPORTED PROBLEM WAS VERIFIED IN THE LAB. THE BATTERY PACK WAS UNABLE TO CHARGE EITHER IN HEARTSTART MRX DEVICE OR A CADEX CHARGER. TROUBLESHOOTING CONDUCTED REVEALED FUSE F1 OPEN. THE FUSE WAS REPLACED AND THE BATTERY OPERATED AS NORMAL. THE CUSTOMER WAS SENT A BATTERY REPLACEMENT. THE BATTERY IS CUSTOMER REPLACEABLE. NO FURTHER ACTION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12390417 ↗
MalfunctionJul 8, 2021Battery Problem; Failure of Device to Self-Test; Battery Problem; Failure of Device to Self-Test
IT WAS REPORTED TO PHILIPS THAT THE RFU INDICATOR DISPLAYED A RED X AND THE ALARM SOUNDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12138031 ↗
MalfunctionJun 28, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CALIBRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12081660 ↗
MalfunctionJun 28, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CALIBRATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12080975 ↗
MalfunctionJun 16, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12010519 ↗
MalfunctionJun 16, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12006274 ↗
MalfunctionJun 16, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12006270 ↗
MalfunctionMay 22, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE DEVICE BATTERY IS NOT RECOGNIZED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11868434 ↗
MalfunctionMay 21, 2021Battery Problem; Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS CALIBRATION BY ONLY BEING ABLE TO CHARGE TO 53%. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11864499 ↗
MalfunctionOct 14, 2019Battery Problem
IT WAS REPORTED TO PHILIPS THAT THE BATTERY IS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9186578 ↗

Device details

UDI-DI	`00884838002791`
Brand	HeartStart
Model	MRx Lithium Ion Battery Module
Catalog no.	M3538A
Company	Philips Medical Systems Hsg
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Feb 28, 2024

Device type (GMDN): Secondary battery

A rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

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All Automated external defibrillators (non-wearable) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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