BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMAN TC BARIATRIC BED

    MDR report key: 3883851 · Received February 13, 2014

    Report

    Report Number
    1824206-2014-00415
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND ONE OF THE REAR THE CASTERS NEEDING TO BE REPLACED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. CASTER WAS REPLACED AND THE ISSUE WAS RESOLVED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM SERVICE TECHNICIAN STATING, "BRAKES SETTING, BUT WILL NOT HOLD." THERE WAS NO PATIENT/USER INJURY REPORTED. T(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96797 REMAN TC BARIATRIC BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. PR1840A000001

    Patients

    Seq Age Sex Outcome Treatment
    1