FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BED
MDR report key: 3896724
·
Received May 20, 2014
Report
- Report Number
- 1824206-2014-01575
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- PMA / PMN Number
- K962942
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND ALL FOUR BRAKE CASTERS NOT HOLDING WHEN SET. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED ALL FOUR BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES ARE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN ENGINEERING. 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 |
|---|---|---|---|---|---|---|---|
| 299184 | TOTAL CARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |