INVOS PMPAMP71 (UDI 10884521780101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521780101), received between Nov 9, 2020 and Nov 6, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Readings” (2 reports).

2 other recalls 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.

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.

• MalfunctionNov 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, WHILE CARDIOPULMONARY RESUSCITATION WAS ONGOING, THE MONITOR BOOTED AND, MEANWHILE, APPLIED THE SENSOR TO THE FOREHEAD OF THE PATIENT. AFTER BEING ABLE TO SEE THE READINGS ON THE MONITOR, THE HCP'S WONDERED WHY THE READING WAS SO LOW (15% RSO2). IMMEDIATELY USED ANOTHER MONITOR, WHICH SHOWED A READING OF 48%, WHEREAS THE OTHER MONITOR STILL SHOWED 15%. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621569 ↗
• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, ONE OF THE TWO VALUES GIVEN BY THE DEVICE WAS TOO LOW WITH 36% WHILE THE TARGET WAS 50%. THE ISSUE WAS ISOLATED TO THE RSC CABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619707 ↗
• MalfunctionJan 17, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE HAD INCORRECT READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18531681 ↗
• MalfunctionJul 28, 2021High Readings; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD INACCURATE READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236473 ↗
• MalfunctionNov 9, 2020Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, THE DEVICE WAS INTERMITTENTLY STOPPED DETECTING RSO2 VALUES. THERE WAS NO ANY ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

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

  MAUDE report 10814189 ↗

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
• Z-1731-2024 · Jan 9, 2024 · Open, Classified
  Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC