MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for POWERLED ARD568350933 manufactured by Maquet Sas.
[187921962]
Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[187922003]
On (b)(6) 2020 getinge became aware of an issue with the one of our surgical light? Powerled. As it was stated by the customer the light was drifting and customer requested service on unit. During the device inspection it has been found that multiple lights and booms on the unit had defective parts and missing pieces. Due to this replacement of the defective parts (dust cover, brakes, light control decal) was performed. After performance verification the device was returned to the customer for further use. No information about injury was provided however we decided to report this case based on potential as any parts falling down from the device might led to contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00073 |
| MDR Report Key | 9903342 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2012-05-23 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERLED |
| Generic Name | LIGHT, SURGICAL, CEILING MOUNTED |
| Product Code | FSY |
| Date Received | 2020-03-31 |
| Model Number | ARD568350933 |
| Catalog Number | ARD568350933 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |