INVOS DS5100C-PARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521185890), received between Mar 19, 2019 and Nov 7, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Readings” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD 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 9293697 ↗
• MalfunctionSep 27, 2019Low Readings; Low Readings

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131620 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS GETTING A 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 9121209 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS GETTING LOW BASELINES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 9121197 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS GETTING LOW BASELINES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 9121191 ↗
• 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 9121173 ↗
• 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 8432926 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE GAVE UNUSUALLY LOW BASELINES (30S AND 40S) ON OTHERWISE HEALTHY ADULT PATIENTS UNDERGOING ROUTINE BEACH CHAIR SHOULDER SURGERIES. THE SENSORS WERE PLACED ON THE PATIENT'S FOREHEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8432904 ↗
• 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 8432870 ↗
• 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 8432839 ↗
• 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 8432751 ↗