R SERIES 10001007201310012Recalls & reported problems

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

All models of R SERIES (94)

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847946017064), received between Jul 7, 2017 and Jul 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Convert Rhythm” (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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Convert Rhythm2
Failure to Deliver Shock/Stimulation1
No Display/Image1

Patient problems

Insufficient Information2
No Clinical Signs, Symptoms or Conditions1
No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 10, 2025Failure to Convert Rhythm; Failure to Convert Rhythm
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A 74-YEAR-OLD FEMALE PATIENT THREE TIMES, THE PATIENT WAS UNABLE TO CONVERT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2025-02538 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 22469871 ↗
MalfunctionJul 10, 2025Failure to Convert Rhythm; Failure to Convert Rhythm
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT AN 82-YEAR-OLD MALE PATIENT THREE TIMES, THE PATIENT WAS UNABLE TO CONVERT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2025-02539 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 22469766 ↗
MalfunctionJun 25, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE FAILED TO DISCHARGE AFTER 10 OR 12 SHOCKS. THE CLINICIAN OBTAINED ANOTHER DEVICE TO TREAT THE PATIENT. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22327526 ↗
MalfunctionJul 7, 2017No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DISPLAY SHOWED DOTS AND WAS NOT LEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6694619 ↗

Device details

UDI-DI	`00847946017064`
Brand	R SERIES
Model	10001007201310012
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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