FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 3893545
·
Received February 15, 2014
Report
- Report Number
- 1824206-2014-00459
- Event Type
- Malfunction
- Date Received
- February 15, 2014
- Date of Event
- January 17, 2014
- Report Date
- January 17, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. A FOLLOW UP REPORT WILL BE SENT ONCE THIS INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE RIGHT INTERMEDIATE SIDE RAIL WILL NOT LATCH. THE BED IS LOCATED ON THE SECOND FLOOR MICU HALLWAY AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99597 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |