FDA Adverse Event
Malfunction
Summary report: N
PRESTIGE VH FOOT REST
MDR report key: 122922
·
Received September 26, 1997
Report
- Report Number
- 57331-1997-00033
- Event Type
- Malfunction
- Date Received
- September 26, 1997
- Date of Event
- August 7, 1997
- Report Date
- September 26, 1997
- Manufacturer
- GENERAL ELECTRIC CO.
- Product Code
- KXJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO GE THAT THE FOOT REST DETACHED WHILE A PT WAS ON IT. NO INJURY WAS REPORTED. FOOT REST HAS BEEN REPLACED WITH A NEWER DESIGN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESTIGE VH FOOT REST | DIAGNOSTIC X-RAY | KXJ | GENERAL ELECTRIC CO. | 2119251 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |