BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV ENDURA

    MDR report key: 1641115 · Received March 15, 2010

    Report

    Report Number
    3003768277-2010-00042
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K010435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM'S COLLIMATOR SUDDENLY CLOSED (SYSTEM FAILURE) WHILE THE PT WAS ON THE TABLE HAVING A FLUOROSCOPIC PROCEDURE. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV ENDURA IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 718074 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA