N
Patient 1
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. DEVICE NOT RETURNED TO MANUFACTURER.
MAUDE MDR 9829252
- MDR report key
- 9829252
- Report number
- 9710055-2020-00038
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-12
- Date received
- 2020-03-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. PASCAL JAY
- Address
- PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | POWERLED II | LAMP, SURGICAL | MAQUET SAS | FTD | ARD268400210A | ARD268400210A | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-13 | 0 |
Event Narratives#
D
Patient 1
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.