BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 2110137 · Received May 19, 2011

    Report

    Report Number
    1824206-2011-02778
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH INVESTIGATED AND COULD NOT DUPLICATE THE MALFUNCTION. NO PROBLEM FOUND. WHEN INSTALLING THE SLIDE-OFF FOOT SECTION, THE AFFINITY 3 USER MANUAL INDICATES THE LATCHES MUST SECURELY ENGAGE AND A LEVEL SURFACE MUST BE ACHIEVED. THE CAREGIVER SHOULD THEN PULL ON THE FOOT SECTION TO ENSURE THAT IT IS LOCKED INTO POSITION. ENSURING THAT THE SLIDE-OFF FOOT SECTION IS PROPERLY LATCHED WILL MITIGATE THE RISK OF THE FOOT SECTION NOT LATCHING OR FALLING FROM THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES A NURSE SAT ON THE FOOT SECTION OF THE BED AND THE FOOT SECTION FELL AND SO DID THE NURSE. NO INJURY.

    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 UNK