BlueSensor PECG Electrodes P-00-S/50Recalls & reported problems
Ambu A/S · ECG electrodes · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480022168), received between Nov 21, 2025 and Nov 24, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Biocompatibility2
Patient problems
- Anaphylactoid / Anaphylaxis2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Biocompatibility; Biocompatibility
PATIENT EXPERIENCED A SEVERE ALLERGIC REACTION WITHIN 5 MINUTES OF THE ELECTRODES BEING APPLIED TO THE SKIN. THEY STARTED TO FEEL ITCHY AND URTICARIA DEVELOPED. THE ELECTRODES WERE REMOVED IMMEDIATELY AND THE SKIN WIPED THOROUGHLY. HOWEVER THE PATIENT THEN BEGAN TO DEVELOP FURTHER SYMPTOMS OF ANAPHYLAXIS. ELECTRODES WERE REMOVED AND PATIENT'S SKIN WIPED THOROUGHLY. APPROPRIATE TREATMENT ADMINISTERED FOR ANAPHYLAXIS. AMBU WAS CONTACTED BY BOTH THE CLINICAL STAFF AND PATIENT TO INQUIRE WHETHER THERE WAS ANY POSSIBILITY THAT THE ELECTRODES MAY CONTAIN LATEX. A DATASHEET AND SKIN REACTION LETTER WAS PROVIDED AND ADVICE GIVEN TO SUBMIT A COMPLAINT.
Patient problems: Anaphylactoid / Anaphylaxis
MAUDE report 23633498 ↗InjuryNov 21, 2025Biocompatibility; Biocompatibility
PATIENT EXPERIENCED A SEVERE ALLERGIC REACTION WITHIN 5 MINUTES OF THE ELECTRODES BEING APPLIED TO THE SKIN. THEY STARTED TO FEEL ITCHY AND URTICARIA DEVELOPED. THE ELECTRODES WERE REMOVED IMMEDIATELY AND THE SKIN WIPED THOROUGHLY. HOWEVER THE PATIENT THEN BEGAN TO DEVELOP FURTHER SYMPTOMS OF ANAPHYLAXIS. ELECTRODES WERE REMOVED AND PATIENT'S SKIN WIPED THOROUGHLY. APPROPRIATE TREATMENT ADMINISTERED FOR ANAPHYLAXIS. AMBU WAS CONTACTED TO INFORM YOURSELVES OF THE INCIDENT BY BOTH THE CLINICAL STAFF AND PATIENT AND ALSO TO ASCERTAIN IF THERE WAS ANY POSSIBILITY THAT THE ELECTRODES MAY CONTAIN LATEX. A DATASHEET AND SKIN REACTION LETTER WAS PROVIDED AND ADVICE GIVEN TO SUBMIT A COMPLAINT.
Patient problems: Anaphylactoid / Anaphylaxis
MAUDE report 23614461 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.