FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1991431
·
Received January 27, 2011
Report
- Report Number
- 1824206-2011-00509
- Event Type
- Malfunction
- Date Received
- January 27, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 14, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE HEAD UP FUNCTION WAS NOT WORKING AND WOULD NOT WORK MANUALLY DUE TO THE HEAD UP VALVE BEING STUCK. REPLACED THE HEAD UP VALVE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
INFO RECEIVED ALLEGED THAT THE HEAD UP WAS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | NONE | FNL | HILL-ROM INC. | P1900C001742-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |