FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3821372
·
Received April 28, 2014
Report
- Report Number
- 1824206-2014-01323
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- March 31, 2014
- Report Date
- March 31, 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 FOUND THE COMMUNICATION CABLE WAS DAMAGED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. HILL-ROM TECHNICAL SUPPORT RECOMMENDED THE COMMUNICATION CABLE BE REPLACED. 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 REPAIR SHOP. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254435 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |