FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BED
MDR report key: 3240961
·
Received July 17, 2013
Report
- Report Number
- 1824206-2013-03533
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 2013
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT CLEANED THE LATCH ASSEMBLY AND REPLACED THE SIDE RAIL LATCH SPRING TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE RIGHT HEAD SIDE RAIL HAS INTERMITTENT LATCH FUNCTION. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332940 | TOTAL CARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |