FDA Adverse Event
Malfunction
Summary report: N
CARE ASSIST BED
MDR report key: 3221312
·
Received July 1, 2013
Report
- Report Number
- 9615739-2013-00184
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 4, 2013
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE CASTER ALIGNMENT VOLT SCREW AND WASHER IS MISSING. THE TECHNICIAN REPLACED THE BRAKE CASTER, ALIGNMENT VOLT SCREW AND WASHER TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THE BRAKES ARE NOT HOLDING. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297389 | CARE ASSIST BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |