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INVOS 5100C-JPRecalls & reported problems

Covidien LP · CEREBRAL/SOMATIC OXIMETER · 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 10884521211186), received between Jun 5, 2020 and Dec 12, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Ambient Noise 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

  • Ambient Noise Problem1
  • Device Alarm System1
  • Patient Device Interaction Problem1

Patient problems

  • Burn(s)1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 12, 2022Device Alarm System; Ambient Noise Problem; Device Alarm System; Ambient Noise Problem

    ACCORDING TO THE REPORTER, DURING SERVICING, THE DEVICE'S ALARM DID NOT SOUND AND HAD FAN'S ABNORMAL NOISE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15958750 ↗
  • InjuryJun 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    ACCORDING TO THE REPORTER, THE PATIENT HAD A BURN IN THE FOREHEAD FROM THE DEVICE. A WOUND CONSULT WAS ORDERED FOR THE PATIENT.

    Patient problems: Burn(s)

    MAUDE report 10124523 ↗

Other Oximeter, tissue saturation devices

All Oximeter, tissue saturation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.