FDA Adverse Event
Malfunction
Summary report: N
VERSACARE
MDR report key: 2492808
·
Received March 13, 2012
Report
- Report Number
- 2492808
- Event Type
- Malfunction
- Date Received
- March 13, 2012
- Report Date
- February 14, 2012
- Manufacturer
- HILL-ROM
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MS, US
Narratives
Description of Event or Problem · 1
THE FACILITY HAS RECENTLY RECEIVED SEVERAL NEW HILL ROM VERSACARE HOSPITAL BEDS. THE BEDS ARE INTERMITTENTLY "LOCKING OUT" AND EVERYTHING JUST STOPS WORKING ON THEM. WHEN THIS OCCURS, THE FACILITY HAS TO CONTACT HILL ROM SERVICE TECHNICIANS TO COME AND ADDRESS THE PROBLEM. THE FACILITY IS WORKING WITH HILL ROM ENGINEERS TO TROUBLESHOOT THE PROBLEM BUT AS OF THE DATE OF THIS REPORT, THE PROBLEM HAS NOT BEEN RESOLVED. CURRENTLY, HILL ROM IS CHANGING THE SIDE RAIL BOARDS AND LOGIC CONTROL BOARDS TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE | HOSPITAL BEDS | FNL | HILL-ROM | P3200J00380 | * | |
| 2 | VERSACARE | HOSPITAL BEDS | FNL | HILL-ROM | P3200J000122 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |