POWERLED
Report
- Report Number
- 9710055-2021-00372
- Event Type
- Malfunction
- Date Received
- December 10, 2021
- Date of Event
- November 4, 2021
- Report Date
- January 21, 2022
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
IT APPEARED THAT THE ISSUE REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4).(REPORT NUMBER: 9710055-2021-00372) IS NOT RELATED TO MAQUET SAS PRODUCT, BUT THE PRODUCT OWNED BY ANOTHER COMPANY (PETER ALBRECHT COMPANY) WHO HAS BEEN INFORMED ABOUT THE COMPLAINT AND FURTHER INVESTIGATION / ADDITIONAL INFORMATION IS AT THEIR DISCRETION. THE COMPLAINT IS THEN CONSIDERED AS CLOSED ON OUR SIDE.
ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.
MANUFACTURER'S REFERENCE NUMBER OT (B)(4).
MANUFACTURER'S REFERENCE NUMBER OT (B)(4).
ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. THE HANDLE OF THE LIGHT HEAD DETACHED FROM THE DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1873075 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |