FDA Adverse Event
Malfunction
Summary report: N
CARE ASSIST BED
MDR report key: 3844778
·
Received March 12, 2014
Report
- Report Number
- 9615739-2014-00105
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 12, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE BRAKE CASTERS HAD DAMAGED STEMS WHICH ALSO DAMAGED THE BRAKE CASTER SUPPORTS. AN INVESTIGATION WAS PERFORMED AND THIS ISSUE WAS ADDRESSED UNDER AN ENGINEERING CHANGE. THE TECHNICIAN REPLACED THE BRAKE CASTER, BRAKE STEER CASTER AND SUPPORTS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE BRAKE CASTERS DO NOT HOLD. THE BED WAS LOCATED IN THE BED REPAIR AREA AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149302 | CARE ASSIST BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |