BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUCKY DIAGNOST

    MDR report key: 1923299 · Received November 2, 2010

    Report

    Report Number
    3003768251-2010-00060
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    PMA / PMN Number
    K945278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY DISPLAYS THE DOSE VALUE AS EITHER 0 (ZERO) OR A DOSE VALUE THAT IS HIGHER THAN THE AVERAGE VALUE DISPLAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUCKY DIAGNOST KPR PHILIPS MEDICAL SYSTEMS 704030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1