Maquet PowerLED II ARDPWT259052ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700712416379), received between Feb 16, 2024 and Nov 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionNov 4, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597216 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 12TH SEPTEMBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 700. IT WAS STATED THE RUBBER GASKET FELL OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321170 ↗
• MalfunctionMay 7, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II 700 . AS IT WAS STATED THE TOP COVER WAS CRACKED AND IT WAS BREAKING INTO SMALL PIECES OF PLASTIC WHICH HAVE THE POTENTIAL TO FALL. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257916 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 18TH DECEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 700. BASED ON DESCRIBED ISSUES, IT WAS NOT POSSIBLE TO DETERMINE IF ANY ISSUE IS SAFETY OR RISK RELATED. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON 19TH JANUARY 2024 INDICATED THERE WAS THE SAFETY SEGMENT SLEEVE MISSING AND THE SNAP RING WAS OUT OF PLACE IN THE SPRING ARM. THERE WAS NO INJURY REPORTED, HOWEVER, BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUES INVESTIGATED HEREIN ARE SAFETY AND RISK RELATED, AS SLEEVE FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE AND THE A SNAP RING BEING OUT OF PLACE IN THE SPRING ARM COULD RESULT IN A DETACHMENT OF SPRING ARM AND DOME AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18718752 ↗