FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BED
MDR report key: 3101669
·
Received April 30, 2013
Report
- Report Number
- 1824206-2013-02413
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND A BENT SIDE RAIL MOUNT AND D-PIN. THE TECHNICIAN REPLACED THE SIDE RAIL MOUNT AND D-PIN TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THE SIDE RAIL WOULD NOT LATCH. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188213 | TOTAL CARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |