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 2019-12-12 for POWERLED II ARDPWT209011A manufactured by Maquet Sas.
[179255218]
The issue is being investigated by the manufacturing site. Other text : device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[179255219]
On (b)(6) 2019 getinge became aware of an issue with surgical light? Powerled ii. As it was stated, down tube cap came loose and fell off into sterile field during case. There was no injury reported however we decided to report the issue in abundance of caution as any falling parts might cause contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2019-00361 |
| MDR Report Key | 9457178 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-12-12 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-05 |
| Date Added to Maude | 2019-12-12 |
| 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 II |
| Generic Name | LAMP, SURGICAL |
| Product Code | FTD |
| Date Received | 2019-12-12 |
| Model Number | ARDPWT209011A |
| Catalog Number | ARDPWT209011A |
| 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 | 2019-12-12 |