BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 1 & 2 BED

    MDR report key: 2823780 · Received October 10, 2012

    Report

    Report Number
    1824206-2012-06332
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT LOWERED THE HEAD SECTION BY PUSHING DOWN ON THE HEAD SECTION WHILE PULLING THE CARDIO RESUSCITATION LEVER. THIS LOOSENS THE HEAD DAMPENER GAS SPRING THAT WAS STUCK TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE HEAD OF THE BED WOULD NOT LOWER WITH THE CARDIO PULMONARY RESUSCITATION LEVER. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 1 & 2 BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1