BlueSensor SPECG Electrodes SP-00-S/10Recalls & reported problems
Ambu A/S · ECG electrodes · Class 2
Data updated Oct 16, 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 05707480027729), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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 16, 2026.
Most reported problems
Device problems
- Defective Device1
Patient problems
- Bradycardia1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2021Defective Device
RESPONDED TO A 911 CALL AS WE ARE EMS FOR OUR DISTRICT. THE PATIENT WAS IN BRADYCARDIA WITH HYPOTENSION. WHEN PREPARING TO PACE THE PATIENT, WE FOUND THAT OUR UNOPENED PACKAGES OF AMBU, BLUESENSOR ELECTRODES WERE COMPLETELY DRIES OUT AND UNUSABLE. WITHOUT ELECTRODES WE ARE NOT ABLE TO PACE. FORTUNATELY THE CREW WAS ABLE TO FIND A PACKAGE THAT WAS NOT DRIED OUT. THESE ELECTRODES ARE NOT SET TO EXPIRE UNTIL NEXT YEAR. THE PACKAGING WAS INTACT AND UNOPENED. LOT #'S - 1000370854 AND 1000421953. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Bradycardia; Low Blood Pressure/ Hypotension
MAUDE report 11744492 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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