BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10 C

    MDR report key: 2020621 · Received February 10, 2011

    Report

    Report Number
    3003768277-2011-00124
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA (B)(4) 2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SHELF OF THE EP EQUIPMENT RACK FELL TO THE FLOOR AND SO DID THE ST. JUDE VELOCITY EQUIPMENT. NO ONE WAS HURT. THIS HAPPENED WHEN THE STAFF WAS PREPARING TO START A PT STUDY. A STAFF MEMBER WAS MOVING THE EP EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 C IZI, MBQ IZI PHILIPS HEALTHCARE 722001

    Patients

    Seq Age Sex Outcome Treatment
    1