BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 15 12 (MONO)

    MDR report key: 1912474 · Received November 22, 2010

    Report

    Report Number
    3003768277-2010-00328
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL 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. (B)(4).

    Description of Event or Problem · 1

    THE VIEWING SUB SYSTEM (VISUB) SHUT OFF DURING AN EXAMINATION AND TURNING THE POWER BACK ON DID NOT ACHIEVE RECOVERY OF THIS X-RAY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 15 12 (MONO) IZI (SYSTEM, X-RAY, ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722043 NA

    Patients

    Seq Age Sex Outcome Treatment
    1