FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 4213872
·
Received October 7, 2014
Report
- Report Number
- 1824206-2014-02408
- Event Type
- Malfunction
- Date Received
- October 7, 2014
- Date of Event
- September 9, 2014
- Report Date
- September 9, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HILL-ROM TECHNICAL SUPPORT SUGGESTED SWAPPING THE SIDE COMMUNICATION BOARD. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2008-2009. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THREE ATTEMPTS HAVE BEEN MADE REGARDING A RESOLUTION TO THIS CONTACT LINE, WITH NO RESPONSE. 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. THE BED WAS LOCATED IN THE MAINTENANCE SHOP. THERE WAS NO PATIENT/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 |
|---|---|---|---|---|---|---|---|
| 629931 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |