FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 2130247
·
Received May 9, 2011
Report
- Report Number
- 9615739-2011-00118
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT'S MAINTENANCE REPLACED THE COMMUNICATION CIRCUIT BOARD TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES, THE PT POSITIONING MONITOR (PPM) ALARMED AT BED SIDE BUT DID NOT PLACE A NURSE CALL AT THE NURSING STATION WHEN THE PT EXITED THE BED. NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAREASSIST BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |