FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 3896359
·
Received May 20, 2014
Report
- Report Number
- 1824206-2014-01585
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE RIGHT HEAD BRAKE CASTER NOT HOLDING DUE TO IT NEEDING TO BE ADJUSTED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2008-2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN ADJUSTED THE BRAKE CASTER 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 RIGHT HEAD BRAKE CASTER IS NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN BED REPAIR. 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 |
|---|---|---|---|---|---|---|---|
| 300829 | ADVANCE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |