BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 2030619 · Received March 22, 2011

    Report

    Report Number
    1824206-2011-01769
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND BROKEN GAS SPRINGS, BENT TREND FOLLOWERS AND A BROKEN BOLT. THE ACCOUNT DID NOT KNOW HOW THIS HAPPENED. THE TECH REPLACED THE GAS SPRINGS, THE TREND FOLLOWERS AND THE BOLT TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE BED IS IN THE LEVEL POSITION AND IT CANNOT BE PLACED INTO TRENDELENBURG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 3 BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1