FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2935184
·
Received December 21, 2012
Report
- Report Number
- 1824206-2012-08447
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN ISOLATED THE ISSUE TO DEBRIS BUILT UP ON THE SIDERAIL LATCH COMPONENTS AND HINGE. HE CLEANED THE SIDERAIL LATCHING COMPONENTS AND HINGE TO REPAIR THE BED. THE BED FUNCTIONED TO SPECIFICATIONS AFTER HE HAD CLEANED THE LATCHING COMPONENTS.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE SIDERAIL WOULD NOT LATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |