BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY

    MDR report key: 1984075 · Received January 14, 2011

    Report

    Report Number
    1824206-2011-00202
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THAT THE HEAD DRIVE NEEDED TO BE REPLACED AND REPLACED THE HEAD DRIVE ASSEMBLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE HEAD SECTION WAS DRIFTING ON THIS BED. NO INJURIES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1