MalfunctionFTD
MAQUET POWERLED II
Received Jun 26, 2026 · Event occurred May 22, 2026
Report 9710055-2026-0000125 · MDR key 25633033
Device
Product problems
- Peeled/Delaminated
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
Description of Event or Problem
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - MAQUET POWERLED II. AS IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE, THE PAINT CHIPPING HAS BEEN OBSERVED ON MAIN TUBE AROUND THE BRAKE SCREW AREA. ACCORDING TO THE INFORMATION PROVIDED, THE DEVICE IS NOT COVERED BY GETINGE SERVICE AGREEMENT. NO PATIENT INVOLVEMENT AND NO INJURY HAVE BEEN REPORTED.