INVOS DS5100C-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521185913), received between Mar 19, 2019 and Jun 27, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT HAD INCORRECT READING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345343 ↗
• MalfunctionSep 29, 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9132611 ↗
• 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 9121203 ↗
• 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 9121193 ↗
• MalfunctionSep 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD INTERMITTENT LOW BASELINES. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 9121186 ↗
• 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 9121082 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434718 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432831 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LOT OF UNUSUALLY LOW BASELINES ON OTHERWISE HEALTHY ADULT PATIENTS UNDERGOING ROUTINE BEACH CHAIR SHOULDER SURGERIES. IT WAS REPORTED THAT AT ONE POINT THEIR PROCUREMENT FOLKS PURCHASED SOME STRYKER RECYCLED SENSORS SO WE THOUGHT THAT WAS MOST LIKELY THE CAUSE OF THEIR PROBLEM, HOWEVER IT HAS CONTINUED AFTER SWITCHING BACK TO THE OEM SENSORS. SEVERAL OF THE CRNA USE DEVICE AT OTHER BJC HOSPITALS, AND HAVE REPEATEDLY TOLD ME THAT THEY DON T SEE THESE LOW BASELINES AT OTHER FACILITIES, AND THAT THEY BELIEVE IT MAY BE A HARDWARE ISSUE. THE CUSTOMER INDICATED THAT THERE WAS PATIENT INVOLVEMENT BUT NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432792 ↗
• MalfunctionMar 19, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LOT OF UNUSUALLY LOW BASELINES ON OTHERWISE HEALTHY ADULT PATIENTS UNDERGOING ROUTINE BEACH CHAIR SHOULDER SURGERIES. IT WAS REPORTED THAT AT ONE POINT THEIR PROCUREMENT FOLKS PURCHASED SOME STRYKER RECYCLED SENSORS SO WE THOUGHT THAT WAS MOST LIKELY THE CAUSE OF THEIR PROBLEM, HOWEVER IT HAS CONTINUED AFTER SWITCHING BACK TO THE OEM SENSORS. SEVERAL OF THE CRNA USES DEVICE AT OTHER BJC HOSPITALS, AND HAVE REPEATEDLY TOLD ME THAT THEY DON T SEE THESE LOW BASELINES AT OTHER FACILITIES, AND THAT THEY BELIEVE IT MAY BE A HARDWARE ISSUE.THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8432755 ↗
• 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 8432551 ↗