FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC BED
MDR report key: 3881594
·
Received February 19, 2014
Report
- Report Number
- 1824206-2014-00511
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- January 22, 2014
- Report Date
- January 22, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- PMA / PMN Number
- K122473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE RUBBER ON THE BRAKE CASTER WHEELS IS WORN CAUSING THE BRAKES TO NOT HOLD WHEN ENGAGED. THE TECH REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECH REPORTED THAT THE BRAKE CASTERS WILL NOT STOP THE BED FROM ROLLING WHEN THE BRAKE IS APPLIED. THE BED WAS LOCATED IN THE HILL-ROM SVC CTR. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104287 | TOTALCARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |