Nellcor PMC10GE360N (UDI 10884521816015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521816015), received between Nov 7, 2024 and Jul 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A FAULTY CORD ERROR, FAILED TO DETECT A GOOD PLETHYSMOGRAPHIC WAVEFORM, AND DISPLAYED RANDOM DROPS IN SPO2 READINGS BELOW THE PATIENT¿S BASELINE. THERE WAS A DISCREPANCY IN OXYGEN SATURATION READINGS, WITH 96% RECORDED IN TRIAGE AND 83% ON THE MONITOR, AND NO GOOD PLETH WAVEFORM WAS DETECTED WITH MULTIPLE PULSE OXIMETER PROBES AND SITES. AUDIBLE AND VISUAL ALARMS FOR LOW OXYGEN SATURATION WERE ACTIVATED. OTHER PULSE OXIMETER PROBES WERE ATTEMPTED ON DIFFERENT FINGERS AND THE FOREHEAD WITHOUT IMPROVEMENT. THE CORD WAS THEN SWAPPED OUT, AND ACCURATE PLETH AND SPO2 READINGS MATCHING THE TRIAGE VALUE WERE CONFIRMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509358 ↗
• MalfunctionJun 26, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT DURING MONITORING A MALFUNCTION OCCURRED ON THE CABLE, CAUSING THE SIGNAL TO RANDOMLY DROP TO THE MONITOR. THE SPO2 READINGS FOR A PATIENT, WHO WAS IN THE EMERGENCY ROOM FOR A WOUND ON THE FOOT, DROPPED FROM 93% TO 60%. THE CABLE WAS REPLACED WITH A NEW ONE, AFTER WHICH THE PATIENT'S SPO2 READINGS REMAINED WITHIN THE NORMAL RANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337141 ↗
• MalfunctionJan 13, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE DISPLAYED INCORRECT SPO2 VALUES WHILE MONITORING A BABY IN AN INCUBATOR SET TO 95% HUMIDITY AT A HOSPITAL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21143779 ↗
• MalfunctionNov 8, 2024Incorrect Measurement; Failure to Analyze Signal; Incorrect Measurement; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, THE CABLE WAS READING FAULTY. IT WAS UNABLE TO DUPLICATE BUT FAILURE CLEARED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645513 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS NOT READING CORRECTLY. THE UNIT WAS SWAPPED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631109 ↗