FDA Adverse Event
Other
Summary report: N
MAQUET S.A.
MDR report key: 737774
·
Received July 7, 2006
Report
- Report Number
- 9710055-2006-00003
- Event Type
- Other
- Date Received
- July 7, 2006
- Report Date
- April 19, 2006
- Manufacturer
- MAQUET S.A.
- Product Code
- FTD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
ASSESSMENT IS THAT THE RUBBER END CAP WAS NOT PROPERLY SEATED. CUSTOMER FACILITY BIOMED REINSTALLED THE CAP BACK INTO ITS PROPER PLACE AND ATTEMPTED TO REMOVE THE CAP ASSURING IT WAS FIRMLY SEATED.
Description of Event or Problem · 1
DURING PROCEDURE, TWO LIGHTS RUBBED LIGHTLY TOGETHER AND A RUBBER END CAP FELL OFF THE LIGHT INTO STERILE FIELD AND ONTO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAQUET S.A. | PRISMALIX SURGICAL LAMP | FTD | MAQUET S.A. | PRX4431 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |