FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2053580
·
Received March 17, 2011
Report
- Report Number
- 1824206-2011-01667
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- January 19, 2010
- Report Date
- January 19, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE CPR VALVE WAS BAD AND WAS NOT LETTING THE HEAD OF THE BED GO DOWN WHEN APPLIED. THE TECHNICIAN REPLACED THE CPR VALVE TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE HEAD OF THE BED WOULD DRIFT DOWN SLOWLY OVERNIGHT. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |