BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST

    MDR report key: 2262036 · Received September 1, 2011

    Report

    Report Number
    3003768251-2011-00061
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POOR IMAGE QUALITY OF PEDIATRIC EXTREMITIES. THE LOSS OF RESOLUTION COULD POTENTIALLY LEAD TO A MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITALDIAGNOST MQB PHILIPS MEDICAL SYSTEMS GMBH DMC 712022

    Patients

    Seq Age Sex Outcome Treatment
    1