FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 4230331
·
Received October 22, 2014
Report
- Report Number
- 9615739-2014-00407
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 25, 2014
- Report Date
- September 25, 2014
- Manufacturer
- HILL-ROM
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE FOOT END CASTERS WERE NOT WORKING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON ITS BEDS. THE TECH REPLACED THE FOOT END CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE FOOT BRAKES WERE NOT HOLDING. THE BED WAS LOCATED ON 4 WEST ROOM. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670703 | CAREASSIST BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |