MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-25 for POWERLED II ARD569201965 ARD569201965 AND ARD569202965 manufactured by Maquet Sas.
[178199742]
Issue is being investigated by manufacturer. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[178199743]
On (b)(6) 2019 getinge became aware of an issue with two surgical lights - powerled ii 500 and 700. As it was stated, the lamp beam caused damage of patient? S skin (burn or lesion) due to too high irradiance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2019-00336 |
| MDR Report Key | 9368762 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-11-17 |
| Date Mfgr Received | 2019-11-18 |
| Date Added to Maude | 2019-11-25 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2019-11-25 |
| Model Number | ARD569201965 |
| Catalog Number | ARD569201965 AND ARD569202965 |
| 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 | 1. Other | 2019-11-25 |