BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV25

    MDR report key: 1522190 · Received October 27, 2009

    Report

    Report Number
    3003768277-2009-00116
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    May 13, 2008
    Report Date
    June 3, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K921255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SWITCH MAY GET STUCK DUE TO MECHANICAL FAILURE OR DUE TO DIRT OR DUST PARTICLES. THIS IS NOT VERY LIKELY SINCE THE REPORTED PROBLEM IS NOT A KNOWN ISSUE. THERE HAVE BEEN NO SIMILAR PROBLEMS OVER THE COMPLETE LIFETIME OF BV25. HOWEVER, WHAT SOMETIMES CAN HAPPEN IS THAT THE SYSTEM IS USED WITH THE FSW PLUS THE USER THEN WRAPS THE CABLE AROUND THE FSW SO TIGHT THAT IT AUTOMATICALLY STARTS TO APPLY X-RAY. THIS IS OUR STRONG SUSPICION. THIS IS CONFIRMED BY THE FACT THAT UPON CHECKING THE SYSTEM, NO DEFECT COULD BE FOUND ON THE CONTROLLER. THE SYSTEM SHOULD BE CHECKED ON ITS SAFETY FUNCTIONS (PROPERLY FUNCTIONING OF X-RAY LAMP, BEEPER, AND HSW/FSW) ON A DAILY BASIS AS STATED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR X-RAY MFR IN (B) (4) TO SUBMIT THIS SITUATION WHICH HAPPENED IN (B) (6). THIS X-RAY SYSTEM'S REMOTE FLUOROSCOPY CONTROLLER GOT STUCK DURING AN EXAM. THE ALARM SOUNDED TO INFORM THE OPERATOR OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV25 IZL [MOBILE X-RAY SYSTEM (C-ARM TYPE)] IZL PHILIPS MEDICAL SYSTEMS 71806 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA