INVOS SPFB/USARecalls & reported problems
Covidien LP · Pediatric SomaSensor Pediatric Disposable Regional Oxygen Saturation Sensor · Class 2
Data updated Oct 13, 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 10884521211162), received between Jan 7, 2019 and Jan 7, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE REPORTER, THE UNIT CAUSED SKIN BURNS TO PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Burn(s)
MAUDE report 8224341 ↗
Other Oximeter, tissue saturation devices
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- HEMOSPHERE FORESIGHT MODULE HEMFSM10Edwards Lifesciences LLC · Oximeter, Tissue Saturation1 recall12 reports
- INVOS PMAC71RICCovidien LP · Oximeter, tissue saturation1 recall4 reports
- FORE-SIGHT ELITE® 01-06-3000Cas Medical Systems, Inc. · Oximeter, Tissue Saturation1 recall1 death2 reports
- Invos 5100C-EUCovidien LP · Oximeter, tissue saturation22 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation21 reports
- INVOS PM7100Covidien LP · Oximeter, tissue saturation18 reports
- INVOS 5100C-PACovidien LP · Oximeter, tissue saturation15 reports
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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