INVOS PMAC71DOCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521780170), received between Aug 7, 2024 and Mar 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K182868); they may or may not involve this specific model.

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.

• MalfunctionMar 2, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING USE, THE MONITOR SHUT DOWN AND THE CIRCULATING NURSE NOTICED THAT THE EQUIPMENT WAS VERY HOT. WHEN THE NURSE TOOK THE MONITOR OUT OF THE HOUSING UNIT, THE DOCKING STATION PINS/PRONGS HAD MELTED AND THE BASE WAS WET. ADDITIONALLY, THE RESIDUE AND LIQUID INSIDE THE MONITOR CAUSED A SHORT CIRCUIT, A SMALL FIRE, AND SMOKE SEEN BY THE STAFF. THE CLEANING FLUID RAN DOWN INTO THE CHARGING CONNECTOR BETWEEN THE BASE AND THE DEVICE. IT WAS NOTED THAT THE DEVICE WAS NOT CLEANED ACCORDING TO THE MANUAL, WHICH CONTRIBUTED TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501299 ↗
• MalfunctionFeb 10, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE EMITTED A HOT AND SMOKING ODOR, AND FLAMES WERE OBSERVED. RESIDUE AND LIQUID WERE NOTED IN THE UNIT, CAUSING A SHORT CIRCUIT, AND THE DOCKING STATION PINS MELTED. RESULTING IN A SMALL FIRE, AND SMOKE WAS SEEN BY STAFF. THE CUSTOMER DID NOT CLEAN THE DEVICE ACCORDING TO THE MANUAL, WHICH CONTRIBUTED TO THE INCIDENT. THE DEVICE WAS SWAPPED TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342964 ↗
• MalfunctionNov 15, 2024Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings; Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD ERRATIC SPO2 READINGS RANGING FROM ZERO TO HIGH VALUES OF 70, 80, AND 90. FURTHERMORE, THE VALUE DISAPPEARED AND THE MONITOR WAS SHOWING AN ALARM OF 'LOW SOUND LEVEL.' THE MONITORS WERE ALSO CONNECTED THROUGH A MODULE TO A MONITOR BY A DIFFERENT MANUFACTURER. ONE CHANNEL ON THE MONITOR WAS SHOWING A FIXED VALUE OF 62, WHILE THE VALUE ON THE OTHER MONITOR WAS CHANGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694839 ↗
• MalfunctionNov 15, 2024Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings; Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD ERRATIC SPO2 READINGS RANGING FROM ZERO TO HIGH VALUES OF 70, 80, AND 90. FURTHERMORE, THE VALUE DISAPPEARED AND THE MONITOR WAS SHOWING AN ALARM OF 'LOW SOUND LEVEL.' THE MONITORS WERE ALSO CONNECTED THROUGH A MODULE TO A MONITOR BY A DIFFERENT MANUFACTURER. ONE CHANNEL ON THE MONITOR WAS SHOWING A FIXED VALUE OF 62, WHILE THE VALUE ON THE OTHER MONITOR WAS CHANGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694784 ↗
• MalfunctionAug 7, 2024Erratic or Intermittent Display; Insufficient Device Problem Information; Erratic or Intermittent Display; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD AN UNSTABLE SYSTEM; IT DID NOT CAPTURE AND HAD A LARGE DATA VARIATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182868. One submission often covers many models, so check the product and lot details in each record.

• Z-1732-2024 · Jan 9, 2024 · Open, Classified
  Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC