FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1984065
·
Received January 14, 2011
Report
- Report Number
- 1824206-2011-00188
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- 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
THE TECHNICIAN FOUND THE HEAD SECTION WILL NOT RISE PAST THIRTY DEGREES. THERE WERE NO ALARMS GOING OFF. THE BATTERY LED WAS LIT. THE HEAD SECTION WOULD NOT RISE WITH THE BED UNPLUGGED AND OPERATING THE HEAD SECTION MANUALLY. THE TECHNICIAN REPLACED THE HEAD UP VALVE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THE HEAD SECTION WILL NOT GO UP. NO ALLEGED INJURY BY ACCOUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |