Ambu WhiteSensor CMMECG Electrodes CMM-00-S/30Recalls & reported problems
Ambu A/S · ECG Electrodes, wet gel, stud connector · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05707480036158), received between Apr 20, 2020 and Apr 20, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES AT AN UNKNOWN HOSPITAL, REPORTED FROM A CUSTOMER LOCATED IN (B)(6). WHITESENSOR ELECTRODES MODEL W-601 WERE USED. THE COMPLAINANT REPORTED "CUST[OMER] HAS REPORTED ISSUE WITH SKIN REACTIONS, NO DETAILS OF PATIENTS OR PICTURES. WHEN REP[RESENTANT] VISITED CUSTOMER THE TECHNICIAN PUT ONE ON HER HAND AND IT WENT RED ALMOST INSTANTLY." WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, IF AND HOW THE SKIN INJURY HAD TO BE TREATED.
Patient problems: Skin Irritation
MAUDE report 9976316 ↗
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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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