FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 3063799
·
Received March 28, 2013
Report
- Report Number
- 1824206-2013-01792
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH REPORTED THAT THE HEAD WOULDN'T RAISE. THE BASE COVER WAS ON THE CPR LEVER CAUSING CPR TO BE ACTIVATED AND WOULDN'T ALLOW HEAD TO RAISE. THE COVER SCREWS WERE MISSING CAUSING THE COVER TO NOT BE SECURE. TECH REPLACED ALL 4 SCREWS TO HOLD COVER IN PLACE AND THE UNIT NOW FUNCTIONS TO SPECS.
Description of Event or Problem · 1
INFO RECEIVED INDICATED THE HEAD SECTION WOULD NOT RAISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127448 | TOTALCARE BARIATRIC | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |