FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 3071196
·
Received April 9, 2013
Report
- Report Number
- 1824206-2013-02049
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SUPPORT RECOMMENDED REPLACING THE HEAD HI/LOW DOWN VALVE OR THE EMERGENCY TRENDELENBURG VALVE. TECHNICAL SUPPORT FOLLOWED UP WITH THE CUSTOMER, HOWEVER, NO OTHER INFORMATION WAS OBTAINED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATED THE HEAD HI-LO DRIFTS DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147895 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |