FDA Adverse Event
Malfunction
Summary report: N
REFURBISHED RITEHITE BED
MDR report key: 3844817
·
Received March 12, 2014
Report
- Report Number
- 1824206-2014-00828
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 12, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- INX
- PMA / PMN Number
- K964223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION THAT THE BRAKE CASTER WAS DAMAGED. THE TECHNICIAN DOES NOT KNOW HOW THE BRAKE CASTER BECAME DAMAGED BUT COULD BE DUE TO TRANSPORT OR NORMAL WEAR AND TEAR. THE TECHNICIAN REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE BED MOVES WHEN THE BRAKE IS SET. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149369 | REFURBISHED RITEHITE BED | BED, AIR FLUIDIZED | INX | HILL-ROM, INC. | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |