FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2862744
·
Received October 12, 2012
Report
- Report Number
- 1824206-2012-06498
- Event Type
- Malfunction
- Date Received
- October 12, 2012
- Date of Event
- September 25, 2012
- Report Date
- September 25, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE LEFT SIDE RAIL USER CONTROL MODULE BOARD TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THE BED HAD NO HEAD UP OR DOWN FUNCTION FROM PT LEFT INTERMEDIATE SIDE RAIL. THE TECHNICIAN ALLEGED FLUID HAD ENTERED INTO THE SIDE RAIL USER CONTROL MODULE BOARD. NO PT IMPACT.
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 |