FDA Adverse Event
Malfunction
Summary report: N
VEST MODEL 104
MDR report key: 1051184
·
Received May 22, 2008
Report
- Report Number
- 1045510-2008-00004
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 23, 2008
- Report Date
- May 22, 2008
- Manufacturer
- HILL-ROM CHARLESTON
- Product Code
- BYI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A POOR ELECTRICAL CONNECTION AT OR WITHIN THE POWER INLET FILTER WAS THE CAUSE OF THE OVERHEATING ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED TO HILL-ROM THAT THE DEVICE CAUGHT FIRE AND REPORTEDLY THE CARPET WAS BURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VEST MODEL 104 | POWERED PERCUSSOR | BYI | HILL-ROM CHARLESTON | 104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |