FDA Adverse Event
Malfunction
Summary report: N
VERSACARE P500 BED
MDR report key: 3843757
·
Received February 12, 2014
Report
- Report Number
- 1824206-2014-00382
- Event Type
- Malfunction
- Date Received
- February 12, 2014
- Date of Event
- January 15, 2014
- Report Date
- January 15, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE CENTER ARM ASSEMBLY OF THE SIDERAIL IS BROKEN. NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. A FOLLOW UP REPORT WILL BE SENT ONCE THIS INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE RIGHT, HEAD SIDERAIL WILL NOT LATCH. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92873 | VERSACARE P500 BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |