BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC DISCOVERY

    MDR report key: 5415855 · Received February 8, 2016

    Report

    Report Number
    5415855
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 20, 2016
    Manufacturer
    HOLOGIC INC
    Product Code
    KGI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN MOVING THE DXA ARM INTO POSITION THE ARM JERKED. THE MACHINE AND EXAM WERE STOPPED. PATIENT RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75979 HOLOGIC DISCOVERY DENSITOMETER, BONE KGI HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR