FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2010019
·
Received March 2, 2011
Report
- Report Number
- 1824206-2011-01210
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 14, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND BED IN STORAGE. FOUND HEAD-HI/LOW SOLENOID VALVE P/N (B)(4) FAILING TO HOLD PRESSURE. REPLACED HEAD-HI/LOW SOLENOID VALVE P/N (B)(4) AND TREND RELEASE VALVE P/N (B)(4) TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
CUSTOMER ALLEGED, THE HEAD-HI/LOW DRIFTS DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900F006105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |