FDA Adverse Event
Malfunction
Summary report: N
HILL-ROM 100 LOW BED
MDR report key: 1191325
·
Received September 26, 2008
Report
- Report Number
- 1824206-2008-03616
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLAINT REVIEW, IT WAS DETERMINED THAT FALSE LATCHING OR NO LATCHING OF SIDERAILS COULD RESULT IN SERIOUS INJURY AND THEREFORE, THIS EVENT WILL BE REPORTED. THE TECHNICIAN DETERMINED THE SPRING MECHANISM FAILED AND REPLACED THE SIDERAIL IN ORDER TO RESOLVE THE PROBLEM.
Description of Event or Problem · 1
WHILE VISITING AN ACCOUNT, A SALES REP NOTICED THAT THE RIGHT HAND SIDERAIL ON THIS BED WOULD NOT LATCH. THERE WAS NO PT IN THE BED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HILL-ROM 100 LOW BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM RITTER | P3930 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |