R SERIES 10000005201310013Recalls & reported problems

Zoll Medical Corporation · Defibrillator ,MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, NIBP, CF/USB, DMST, REFURB, REFURB · Class 3

All models of R SERIES (94)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946002053), received between Sep 15, 2017 and Jan 3, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (2 reports).

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 16, 2026.

Most reported problems

Device problems

Failure to Power Up2
Defibrillation/Stimulation Problem1
Device Displays Incorrect Message1
Failure to Deliver Shock/Stimulation1

Patient problems

No Patient Involvement5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 3, 2020Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9545914 ↗
MalfunctionSep 16, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 72" AND "DEFIB FAULT 76" MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9071447 ↗
MalfunctionFeb 21, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8359434 ↗
MalfunctionJun 13, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB FAULT 76" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7598342 ↗
MalfunctionSep 15, 2017Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6870056 ↗

Device details

UDI-DI	`00847946002053`
Brand	R SERIES
Model	10000005201310013
Company	Zoll Medical Corporation
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	MR Unsafe
Status	In Commercial Distribution
Record updated	Jan 28, 2026

Device type (GMDN): Rechargeable professional automated external defibrillator

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.

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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
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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