FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1991405
·
Received January 27, 2011
Report
- Report Number
- 1824206-2011-00504
- 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THE BED IN THE BED SHOP. THE HD HI/LOW DRIFTED DOWN OVERNIGHT WHEN LEFT IN HIGH POSITION. FOUND THAT THE HYDRAULIC SYSTEM WAS WORKING CORRECTLY, BUT THAT THE HI/LOW DOWN VALVE ALLOWED DRIFTING. REPLACED PART # (B)(4) TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
ON (B)(6) 2011 - THE HD HI/LOW DRIFTED DOWN OVERNIGHT WHEN LEFT IN HIGH POSITION. (B)(4). BEDSHOP. NO OBV ABS. SUM - FOUND THE HYDRAULIC SYSTEM WORKING CORRECTLY AND HI/LOW DOWN VALVE ALLOWED DRIFTING - SLOWLY REP'D (B)(4) TO FIX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900M007063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |