BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV 25 GOLD 9"

    MDR report key: 1888326 · Received October 20, 2010

    Report

    Report Number
    3003768277-2010-00259
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K921255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE FUSES POP OUT DURING OPERATION. THIS HAPPENS W/O AN ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV 25 GOLD 9" IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 71817 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA