NA E-sCO-00Recalls & reported problems
GE Healthcare Finland Oy · E-SCO-00, MODULE ASSEMBLY · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840682104173), received between Apr 2, 2024 and Apr 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Run on Battery” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Run on Battery1
- Mechanical Problem1
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.
MalfunctionApr 9, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN PROLONGED INSUFFICIENT OXYGEN FLOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19072643 ↗MalfunctionApr 2, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19017040 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.