N/A 2464AAORecalls & reported problems
AirLife Finland Oy · Leg Attachment Pad for Corometrics; Fetal Scalp Electrode Cable · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752145337), received between Nov 9, 2022 and Jan 23, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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.
Most reported problems
Device problems
- Connection Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2023Connection Problem; Connection Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LED PAD ATTACHMENT FOR COROMETRICS FETAL SCALP ELECTRODE CABLE CANNOT STAY CONNECTED DURING USE. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16229671 ↗InjuryNov 9, 2022Connection Problem; Connection Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE PADS, FETAL SCALP ELECTRODE ATTACHMENT KEEPS COMING OFF, MAKING IT IMPOSSIBLE TO MONITOR THE BABY'S HEART RATE. RECURRENT LATE AND PROTRACTED DECELERATIONS WERE OCCURRING IN THE PATIENT. TWO DIFFERENT FSE GROUNDING PADS WERE USED BUT THE DEVICE CONTINUED TO FALL OFF OF THE PAD. ADDITIONALLY, THERE WAS NO INFORMATION ON PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15765019 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.