BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDIAGNOST ELEVA

    MDR report key: 1942907 · Received December 17, 2010

    Report

    Report Number
    3003768251-2010-00070
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING AND CONCLUSIONS WILL BE SENT IN A F/U REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PEDIATRIC IMAGES ARE OF POOR IMAGE QUALITY ESPECIALLY THE EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYDIAGNOST ELEVA KPR PHILIPS MEDICAL SYSTEMS 706034 NA

    Patients

    Seq Age Sex Outcome Treatment
    1