BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA

    MDR report key: 1823438 · Received August 27, 2010

    Report

    Report Number
    3003768277-2010-00168
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K010435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS, CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE X-RAY SYSTEM IS GENERATING A SYSTEM FAILURE "M050" ERROR MESSAGE. ALSO, THE CUSTOMER ALLEGES LIQUID IS GETTING INSIDE THE IMAGE INTENSIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 718094 NA

    Patients

    Seq Age Sex Outcome Treatment
    1