FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE
MDR report key: 2053555
·
Received March 17, 2011
Report
- Report Number
- 1824206-2011-01671
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- March 17, 2010
- Report Date
- March 17, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT SWAPPED THE BED OUT. NO INFO AVAILABLE ON THE REPAIR OF THIS BED. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
ACCOUNT ALLEGED THAT THE BED LOST POWER AND WOULD NOT COME BACK ON. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL CARE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |