FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 1882711
·
Received October 21, 2010
Report
- Report Number
- 1824206-2010-10611
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- September 28, 2010
- Report Date
- October 1, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BED WOULD NOT GO INTO TRENDELENBURG. THE PROBLEM IS IN THE RIGHT SIDERAIL CAREGIVER ASSEMBLY. THE BED IS IN THE ICU AND A PATIENT WAS IN THE BED WHEN THE PROBLEM WAS DISCOVERED. THE PATIENT WAS NOT INJURED. THE ACCOUNT REPLACED THE RIGHT SIDERAIL CAREGIVER ASSEMBLY TO REPAIR THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM, INC. | 3201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |