FDA Adverse Event
Other
Summary report: N
VITEK32
MDR report key: 569110
·
Received January 18, 2005
Report
- Report Number
- 569110
- Event Type
- Other
- Date Received
- January 18, 2005
- Date of Event
- December 9, 2004
- Report Date
- January 12, 2005
- Manufacturer
- BIOMERIEUX VITEK, INC
- Product Code
- LIB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
UPS FOR VITEK32 BECAME VERY HOT AND SMELLED LIKE "HOT WIRING". THERE HAD BEEN A SHORT POWER INTERRUPTION THE PREVIOUS NIGHT. IT APPEARED TO BE OPERATING ON BATTERY MODE EVEN THOUGH ELECTRICITY HAD BEEN RESTORED. TECHNICAL SERVICES SAID TO DISCONNECT IMMEDIATELY AFTER GOING THROUGH CHECK POINTS. VITEK SHIPPED A NEW UPS OVERNIGHT AND WAS SYSTEM FULLY RESTORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITEK32 | MICROBIOLOGY SYSTEM | LIB | BIOMERIEUX VITEK, INC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |