INVOS IS-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521211121), received between Jul 18, 2018 and Feb 7, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT CONTAMINATED WITH EVIDENCE OF FUNGAL CUTANEOUS ASPERGILLUS. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682687 ↗
• InjuryJul 25, 2018Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BLISTER ABOUT THE SIZE OF A PIECE OF RICE. THE CUSTOMER REPORTED THAT IT MAY BE A DESIGN ISSUE.

  Patient problems: Skin Irritation; Swelling

  MAUDE report 7717769 ↗
• InjuryJul 18, 2018Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD CAUSED BREAKDOWN, A SMALL PRESSURE STAGE 2 BLISTER ABOUT THE SIZE OF A PIECE OF RICE OCCURRED ON TWO OF THEIR PATIENTS.

  Patient problems: No Code Available; Skin Irritation

  MAUDE report 7700979 ↗