FDA Adverse Event
Malfunction
Summary report: N
P425 MANUAL BED
MDR report key: 1210125
·
Received October 20, 2008
Report
- Report Number
- 1824206-2008-03856
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 22, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HEAD SECTION DRIFTING IS UNINTENTIONAL MOVEMENT OF THE BED WHICH HAS THE POTENTIAL TO CAUSE SERIOUS INJURY. A NEW DRIVE SCREW WAS SENT TO THE ACCOUNT TO RESOLVE THE PROBLEM, BUT ATTEMPTS TO DETERMINE FINAL RESOLUTION HAVE GONE UNANSWERED AT THIS TIME.
Description of Event or Problem · 1
AN ACCOUNT STATED THAT THE HEAD SECTION ON THIS BED WOULD DRIFT DOWN ONCE RAISED. THERE WAS A PT ON THE BED AT THIS TIME, BUT THERE WERE NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | P425 MANUAL BED | MANUAL HOSPITAL BED | FNJ | HILL-ROM RITTER | P425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |