FDA Adverse Event
Malfunction
Summary report: N
VIP 2000
MDR report key: 109284
·
Received July 24, 1997
Report
- Report Number
- 1810909-1997-00010
- Event Type
- Malfunction
- Date Received
- July 24, 1997
- Date of Event
- May 28, 1997
- Report Date
- July 22, 1997
- Manufacturer
- BAYER CORP.
- Product Code
- IEO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING THE PROCESSING OF TISSUE SAMPLES A LEAK DEVELOPED IN THE SYS "SPILLIN" XYLENE IN THE LAB. THE LAB COULD NOT BE ENTERED UNTIL FUME CONTROL AND BREATHING PROTECTION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIP 2000 | TISSUE PROCESSOR | IEO | BAYER CORP. | 4618B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |