FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC BED
MDR report key: 3893542
·
Received February 14, 2014
Report
- Report Number
- 1824206-2014-00436
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 16, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- PMA / PMN Number
- K122473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND A BENT SIDE RAIL LATCH COVER IS THE CAUSE OF THE ISSUE. THE TECHNICIAN REPLACED THE LEFT FOOT SIDE RAIL LATCH COVER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE LEFT FOOT SIDE RAIL IS NOT LATCHING. THE BED IS LOCATED AT THE HILL-ROM SERVICE CENTER. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98915 | TOTALCARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |