BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY THREE BED

    MDR report key: 3896295 · Received May 20, 2014

    Report

    Report Number
    1824206-2014-01543
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE BRAKE DETENT WAS BROKEN. PER THE HILL-ROM SERVICE MANUAL THE AFFINITY THREE BIRTHING BED AND AFFINITY FOUR BIRTHING BEDS REQUIRE AND EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM SEMIANNUAL PREVENTIVE 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. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2010-2012. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE ACCOUNT REPLACED THE BRAKE DETENT 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 BRAKES WERE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILE DIN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300854 AFFINITY THREE BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1