BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI

    MDR report key: 1100647 · Received August 6, 2008

    Report

    Report Number
    MW5007921
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 6, 2008
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAILURE TO SUPPLY INSTALLATION INFO FOR PROPER INSTALLATION OF UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI HITACHI AIRIS II MRI LNH

    Patients

    Seq Age Sex Outcome Treatment
    1