BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIGITAL DIAGNOST SINGLE DETECTOR

    MDR report key: 2492443 · Received March 9, 2012

    Report

    Report Number
    3003768251-2012-00007
    Event Type
    Other
    Date Received
    March 9, 2012
    Report Date
    February 12, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE EVA = EXAMINATION PROGRAMMED X-RAY VALIDATION AND ADMINISTRATION DATABASE. THE PRELIMINARY INVESTIGATION INDICATES THAT THE APPLICATION SPECIALIST INADVERTENTLY CHANGED THE CONFIGURATION OF THE DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL DIAGNOST SINGLE DETECTOR MQB, KPR MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712020

    Patients

    Seq Age Sex Outcome Treatment
    1