INVOS SPFB/INTLRecalls & reported problems
Covidien LP · Pediatric SomaSensor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521105918), received between Feb 7, 2022 and Mar 8, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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
- Patient Device Interaction Problem4
Patient problems
- Pressure Sore/Ulcer4
- Burn(s)1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD CAUSE SKIN PRESSURE INJURY ON FOREHEAD. PRESSURE SORES THAT RESOLVED QUICKLY.
Patient problems: Pressure Sore/Ulcer
MAUDE report 13686039 ↗MalfunctionMar 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CAUSED SKIN PRESSURE INJURY LOCATED ON LEFT FLANK. THE PATIENT HAD TEMPORARY WOUND.
Patient problems: Pressure Sore/Ulcer
MAUDE report 13685967 ↗MalfunctionMar 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD PRESSURE INJURY AT THE FOREHEAD AND BACK AND HAD TEMPORARY WOUND.
Patient problems: Pressure Sore/Ulcer
MAUDE report 13685895 ↗MalfunctionFeb 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO THE REPORTER, THE CHILD'S BACK BURNED BY THE SENSOR AFTER LONG SURGERY (LIVER TRANSPLANT, 12 HOURS). EITHER A PRESSURE ULCER OR A SENSOR BURN BECAUSE UNFORTUNATELY THE LESION WAS DISCOVERED A FEW DAYS AGO. THE PATIENT HAD BURNED.
Patient problems: Burn(s); Pressure Sore/Ulcer
MAUDE report 13472118 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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