FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 3031333
·
Received March 5, 2013
Report
- Report Number
- 1824206-2013-01224
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 5, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECH REPLACED THE HEAD DOWN AND TREND VALVES TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATED THE HI/LO SECTION DRIFTS DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94890 | TOTALCARE BARIATRIC | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |