BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 1912444 · Received November 4, 2010

    Report

    Report Number
    3003768277-2010-00281
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS): ROOT CAUSE WAS FOUND IN BLOWN FUSE, TWICE, IN THE MAIN POWER DISTRIBUTION CONTROL UNIT. AFTER REPLACEMENT OF THE MPD CONTROL UNIT, THE PROBLEM WAS SOLVED. BASED ON TRENDING ANALYSIS WE CONCLUDE THAT THIS PART HAS NO EXCEPTIONAL REPLACEMENT RATE. NO PATIENT INJURY REPORTED. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A BLOWN FUSE ON THE MAIN POWER DISTRIBUTION (MPD) UNIT. THIS OCCURRED DURING A PATIENT EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA