BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE

    MDR report key: 3883840 · Received February 13, 2014

    Report

    Report Number
    1824206-2014-00421
    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
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE STEER/BRAKE CASTER WAS RATCHETING AND WOULD NOT HOLD. HE REPLACED THE STEER/BRAKE CASTER AND THE ISSUE WAS RESOLVED. THE MOST LIKELY CAUSE FOR THIS FAILURE IS WEAR. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN ONCE IN 2012 AND ONCE IN 2013.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM HILL-ROM SERVICE TECHNICIAN STATING, "THE STEER CASTER WAS RATCHETING AND WOULD NOT HOLD." THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96734 TOTAL CARE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1900D003346

    Patients

    Seq Age Sex Outcome Treatment
    1