INVOS PMAC71RICRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521806436), received between Nov 18, 2024 and May 21, 2025 — classified as 4 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K182868, K211561); 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.

Recalls naming this device

1. Jan 9, 2024Open, Classified

   manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

   Z-1731-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR PRODUCED "POOR SIGNAL QUALITY" ERROR. IT WAS DISCOVERED AFTER OTHER RIC CABLE WAS USED AND SENSOR WAS CHECKED SEPARATELY. TROUBLESHOOTING WAS SWAPPED CABLES, SENSORS, PREAMPS AND WAS ISOLATED TO RIC CABLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061697 ↗
• MalfunctionDec 5, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED DURING THE PROCEDURE, ERRATIC SPO2 AND RSO2 READINGS WERE OBSERVED, FLUCTUATING BETWEEN 15 AND 80. INITIALLY, CEREBRAL READINGS HAD BEEN STABLE FOR THE FIRST HOUR BUT LATER BECAME ERRATIC, WHILE RENAL SENSOR READINGS REMAINED STABLE. THERE HAD BEEN INSTANCES OF BAD OR LOST SIGNALS, ACCOMPANIED BY A YELLOW VISUAL ALARM. NO BASELINE READING HAD BEEN ESTABLISHED BEFORE THE PROCEDURE, AND THE PATIENT'S POSITION CHANGE STATUS WAS UNKNOWN. TWO CHANNELS HAD BEEN IN USE DURING THE EVENT. IMPORTANTLY, NO PATIENT HARM HAD OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852052 ↗
• MalfunctionNov 18, 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. IN ADDITION STRANGE READINGS DEFINED AS CORRUPTED, CABLES AND PRE-AMPLIFIERS WERE USED ALONG WITH THE MONITOR AND VISUAL ALARM SHOWED IN YELLOW. THERE WAS NO SOUND/NO SIGNAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716003 ↗
• MalfunctionNov 18, 2024Erratic or Intermittent Display; High Readings; Low Readings; 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. IN ADDITION STRANGE READINGS DEFINED AS CORRUPTED, CABLES AND PRE-AMPLIFIERS WERE USED ALONG WITH THE MONITOR AND VISUAL ALARM SHOWED IN YELLOW. THERE WAS NO SOUND/NO SIGNAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715332 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182868, K211561. 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