FDA Adverse Event
Malfunction
Summary report: N
VERSACARE P500 BED
MDR report key: 3883829
·
Received February 13, 2014
Report
- Report Number
- 1824206-2014-00414
- Event Type
- Malfunction
- Date Received
- February 13, 2014
- Date of Event
- January 14, 2014
- Report Date
- January 14, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE COMMUNICATION CARD IN THE NURSE COMMUNICATION BOARD WAS DEFECTIVE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM DID NOT PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE NURSE COMMUNICATION BOARD FOR THE NURSE CALL SYSTEM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE NURSE CALL WOULD NOT WORK. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96665 | VERSACARE P500 BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |