FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC PLUS
MDR report key: 2842253
·
Received November 8, 2012
Report
- Report Number
- 1824206-2012-07279
- Event Type
- Malfunction
- Date Received
- November 8, 2012
- Date of Event
- March 28, 2012
- Report Date
- March 28, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN TESTED THE HEAD SECTION FOR DRIFT WITH 200LBS OF WEIGHT AND COULD NOT DUPLICATE THE ALLEGED MALFUNCTION. THE TECHNICIAN PERFORMED AN OPERATION CHECK AND FOUND THE BED FUNCTIONING PROPERLY.
Description of Event or Problem · 1
THE COMPLAINANT STATED THAT THE HEAD OF THE BED DRIFTS DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC PLUS | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |