POWERLED Adverse Event — Malfunction (MDR 9710055-2020-00093)
POWERLED Adverse Event — Malfunction (MDR 9710055-2020-00093) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERLED; Generic name: LIGHT, SURGICAL, CEILING MOUNTED; Manufacturer: MAQUET SAS.
| Device | POWERLED |
|---|---|
| Generic name | LIGHT, SURGICAL, CEILING MOUNTED |
| Manufacturer | MAQUET SAS |
| Report number | 9710055-2020-00093 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | GETINGE BECAME AWARE OF AN ISSUE WITH A SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED, A GAP BETWEEN THE SF 700 FORK AND SPRING ARM WAS NOTICED. PROVIDED PHOTOGRAPHIC EVIDENCES WERE IN LINE WITH RECEIVED ALLEGATION AND REVEALED AN ADDITIONAL ISSUE WITH THE SURGICAL LIGHT, NAMELY A PROBLEM WITH PAINT CHIPPING ON THE DEVICE, NEAR THE KEYPAD AREA. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO |
| Source | openFDA MAUDE (device adverse events) |
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