MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for POWERLED II ARD268400210A manufactured by Maquet Sas.
[183487405]
The issue is being investigated by manufacturing site. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[183487406]
On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - powerled ii. As it was stated, customer said that patient had a dark spot on the skin exposed to the surgical light that wasn't there before the case. It was not established what exactly caused the discoloration however we decided to report the issue in abundance of caution as excessive heat from light head may lead to serious injury or worse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00038 |
| MDR Report Key | 9829252 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Model Number | ARD268400210A |
| Catalog Number | ARD268400210A |
| 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 | 2020-03-13 |