FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 4203561
·
Received September 17, 2014
Report
- Report Number
- 1824206-2014-02276
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 20, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE NURSE CALL WAS NOT TURNED ON. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THEIR BEDS.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE NURSE CALL WOULD NOT WORK. THE BED WAS LOCATED IN ORTHO-NEURO. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS MAILED IN OUR COMPLAINT HANDLING SYS AS COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575300 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |