FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 3881591
·
Received February 19, 2014
Report
- Report Number
- 1824206-2014-00509
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- January 22, 2014
- Report Date
- January 22, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE SIDE RAIL LATCHING MECHANISM IS DIRTY AND STICKY FROM FLUID EGRESS. THE TECH CLEANED AND LUBRICATED THE SIDE RAIL LATCH MECHANISM TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECH REPORTED THE SIDE RAIL WOULD NOT LATCH IN THE UP POSITION. THE BED IS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104234 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |