FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 1830095
·
Received September 7, 2010
Report
- Report Number
- 9615739-2010-00211
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- August 12, 2010
- Report Date
- August 12, 2010
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE BAR WAS NOT ENGAGING THE BRAKE SET SENSOR AND WHEN HE MOVED THE BED AROUND, THE RIGHT FOOT END CASTER MOVED MORE THAN IT SHOULD WHEN IN BRAKE. THE TECH FOUND THE CASTER SUPPORT WAS CRACKED IN HALF. THE TECH REPLACED THE CASTER SUPPORT TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKE IS NOT SET AND THE BED IS ALARMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAREASSIST BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |