Maquet PowerLED II ARDPWT239221ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712412593), received between Oct 7, 2024 and Oct 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unexpected Shutdown” (1 report).

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

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. Nov 8, 2023Open, Classified

   A potential for a light system to fall in the operating room.

   Z-0757-2024 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Unexpected Shutdown; Unexpected Shutdown

  ON 25TH SEPTEMBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHT - MAQUET POWERLED II. IT WAS STATED THAT THERE WAS A POWER FAILURE AND THE BATTERY SUPPLY DID NOT WORK. THEREFORE THE LIGHTS WENT OUT DURING THE OPERATION AND THE SURGEON WAS IN THE DARK. ONLY WHEN THE EMERGENCY POWER GENERATOR WAS STARTED UP FOR THE OPERATION DID THEY LIGHT UP AGAIN. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE EXTINCTION OF SURGICAL LIGHT SYSTEM DURING PROCEDURE MAY CAUSE SERIOUS INJURY IN CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380732 ↗