FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1964192
·
Received December 21, 2010
Report
- Report Number
- 1824206-2010-11862
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- December 8, 2010
- Report Date
- December 8, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE CAUSE OF THE ISSUES WAS THE TOP CENTER BASE SHROUD WAS BENT AND HOLDING DOWN THE CPR/TREND BAR, CAUSING THE BED FUNCTIONS TO NOT WORK. REPLACED THE TOP CENTER COVER SHROUD TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
FACILITY ALLEGED THAT THE BED WAS STUCK IN TREND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900E005009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |