Maquet PowerLED II ARDPWT229139ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700712406837), received between Sep 5, 2023 and Nov 29, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 22ND NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 700. IT WAS STATED THE IMPACT SHOCK MOVED THE REAR COVER SIDE WAYS AND SPLIT THE KIT. THEN, AS THE USER MOVED THE SURGICAL LIGHT UP AND DOWN, THE DUST COVER MOVED FORWARD. THE TECHNICIAN INFORMED THE METAL PLATE INSIDE THE COVER DETACHED. 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 OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225806 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682452 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682450 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682447 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682445 ↗