FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC BED
MDR report key: 3240830
·
Received July 16, 2013
Report
- Report Number
- 1824206-2013-03511
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 19, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE SIDE RAIL ASSEMBLY AND CENTER ARM WERE CRACKED. THE TECHNICIAN REPLACED THE SIDE RAIL ASSEMBLY AND CENTER ARM TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THE SIDE RAIL WOULD NOT LATCH IN THE UP POSITION. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330360 | TOTALCARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |