Nellcor PMC10NFH-GERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521780682), received between Apr 5, 2023 and May 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2023Device Alarm System; Erratic or Intermittent Display; Failure to Analyze Signal; Device Alarm System; Erratic or Intermittent Display; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, THE CABLE GAVE FLUCTUATING SPO2 AND PULSE RATE NUMBERS THAT DID NOT REPRESENT THE ACTUAL PATIENT CONDITIONS WHEN CHECKED WITH A HANDHELD MONITOR AND A SENSOR. THE SPO2 NUMBER DRIFTED LOW, AND THE PULSE RATE DROPPED TO NO DISPLAY OR DRIFTED VERY HIGH. ON OCCASION, THE SPO2 VALUES DISPLAYED 3% OR DROPPED OUT ENTIRELY. DRIFTING SPO2 READINGS CAUSED LIMIT ALARMS TO TRIP. THE PATIENT WAS CHECKED AND REPORTED TO HAVE GOOD NORMAL NUMBERS USING A HANDHELD OXIMETER. THE SENSOR WAS CHECKED AND REPLACED, THE CABLES AND TELEMETRY MODULES WERE REPLACED, AND THE SAME DRIFTING OF NUMBERS WOULD REPEAT. IT PRODUCED A VISUAL ALARM AT THE CENTRAL STATION, BUT NO AUDIBLE ALARM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991939 ↗
• MalfunctionApr 5, 2023Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE UNIT HAD NO ALARMS AND THE SPO2 AND PULSE RATE INFORMATION CONTINUED TO BE PROVIDED THOUGH THE PATIENT EXPIRED. ADDITIONAL INFORMATION TO DETERMINE THE DEVICE RELATIONSHIP TO THE EVENT HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16681195 ↗