FDA Adverse Event
Malfunction
Summary report: N
VERSACARE
MDR report key: 1250005
·
Received November 14, 2008
Report
- Report Number
- 1824206-2008-04179
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- October 15, 2008
- Report Date
- October 16, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN INVESTIGATED AND FOUND THE RIGHT SIDERAIL WAS DAMAGED AND THE SCALE POD EXITING SWITCH WAS NOT WORKING. THE BEDS MAINTENANCE INDICATOR WAS ALSO LIT. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE NURSE ALLEGED A PT WAS FOUND ON THE FLOOR. THE NURSE STATED BOTH SIDERAILS WERE IN THE UP POSITION ON THE SIDE OF THE BED WHERE THE PT EXITED. SHE DID NOT KNOW IF PPM WAS ARMED. THE PT HIT HIS HEAD AND HAD A CUT ON HIS RIGHT SHOULDER. THE CUT WAS TREATED WITH A BANDAGE AND IN ADDITION THE HOSPITAL PERFORMED A CT SCAN ON THE PT'S HEAD AND NO FURTHER TREATMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE | AC POWERED HOSPITAL BED | FNL | HILL-ROM RITTER | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |