BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 6030216 · Received October 13, 2016

    Report

    Report Number
    MW5065379
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 29, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, A BURNING SMELL WAS FIRST NOTICED AND WITHIN MOMENTS A LOUD POPPING AROUND OCCURRED AND THE PHILIPS CATH LAB EQUIPMENT SHUT OFF. IT WAS ALSO NOTICED THE WALL BREAKER HAD TRIPPED. THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677706 PHILIPS MEDICAL SYSTEMS ALLURA XPER FD10 IZI PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR