BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY THREE BIRTHING BED

    MDR report key: 3883282 · Received February 20, 2014

    Report

    Report Number
    1824206-2014-00533
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE BRAKE CASTER AND BRAKE STEER CASTER ROTATE TO THE SIDE. PER THE HILL-ROM SERVICE MANUAL, THE AFFINITY THREE BIRTHING BED AND AFFINITY FOUR BIRTHING BEDS REQUIRE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM SEMI-ANNUAL PREVENTATIVE MAINTENANCE. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. APPLY THE BRAKE, AND CHECK TO ENSURE THAT THE BED WILL NOT MOVE. IF THE BED MOVES, INSPECT IT FOR WEAR, AND ADJUST IF REQUIRED. APPLY THE STEERING PEDAL AND CHECK THE STEERING TO ENSURE PROPER LOCKING ACTION WHEN ACTIVATED. THE ACCOUNT REPLACED THE BRAKE CASTER AND BRAKE STEER CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKE CASTER AND BRAKE STEER CASTERS DO NOT HOLD WHILE IN BRAKE MODE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106806 AFFINITY THREE BIRTHING BED BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1