INVOS DS5100C-PBRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521185906), received between Mar 19, 2019 and Sep 25, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Low Readings” (10 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD INTERMITTENT LOW BASELINES ON HEALTHY PATIENTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9121210 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD INTERMITTENT LOW BASELINES ON HEALTHY PATIENTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9121207 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD INTERMITTENT LOW BASELINES. THEY WERE GETTING LOW BASELINES ON HEALTHY PATIENTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9121206 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD INTERMITTENT LOW BASELINES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9121168 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD INTERMITTENT LOW BASELINES ON ALL OF THE MONITORS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9121075 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READING. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432873 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW BASELINES ON HEALTHY ADULT PATIENT UNDERGOING ROUTINE BEACH CHAIR SHOULDER SURGERY AND SHOULD NOT HAVE LOW BASELINE. IT WAS REPORTED THAT BASELINES WERE 30S AND 40S. THE SENSORS WERE PLACED ON THE PATIENT'S FOREHEAD. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432782 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW BASELINES ON HEALTHY ADULT PATIENT UNDERGOING ROUTINE BEACH CHAIR SHOULDER SURGERY AND SHOULD NOT HAVE LOW BASELINE. IT WAS REPORTED THAT BASELINES WERE 30S AND 40S. THE SENSORS WERE PLACED ON THE PATIENT'S FOREHEAD. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432711 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW READINGS.THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432639 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW BASELINES ON HEALTHY ADULT PATIENT UNDERGOING ROUTINE BEACH CHAIR SHOULDER SURGERY AND SHOULD NOT HAVE LOW BASELINE. IT WAS REPORTED THAT BASELINES WERE 30S AND 40S. THE SENSORS WERE PLACED ON THE PATIENT'S FOREHEAD. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432593 ↗