HEARTBEAT 1925-100Recalls & reported problems
Conmed Corporation · HEARTBEAT RESTING TAB ECG ELECTRODE · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405033714), received between Jul 25, 2022 and Jul 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 1925-100, HEARTBEAT;100;TAB;ADGEL, WAS REPORTED AS USED DURING AN URGENT ECG ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿NEW ECG ELECTRODES THAT CAME WITH THE NEW GE MACVU 360 ECG MACHINE, DO NOT ADHERE TO PATIENTS WELL. MULTIPLE COMPLAINTS FROM NURSING AND LAB. MOST RECENT INCIDENT WAS A PATIENT NEEDING AN URGENT ECG AND WE COULD NOT OBTAIN A TRACING. RAN OVER TO LAB TO FIND SOME OLDER PRODUCT (KENLOR/COVIDIEN PADS) AND THE ECG WAS COMPLETED.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS REPORTED AS BEING COMPLETED WITH AN ALTERNATE PAD. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15094835 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.