BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL DIAGNOST

    MDR report key: 2211940 · Received August 10, 2011

    Report

    Report Number
    3003768251-2011-00054
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 14, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    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

    THE INVESTIGATION IS CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A FOLLOW UP REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POOR IMAGE QUALITY WITH PEDIATRIC IMAGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1