FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2000068
·
Received February 3, 2011
Report
- Report Number
- 1824206-2011-00642
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 5, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO CHECK THE CPR LINKAGE AND THE CPR VALVE. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE CPR WILL NOT LOWER THE HEAD, BUT HEAD CAN BE LOWERED BY USING THE BUTTON ON THE SIDERAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |