BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 2864492 · Received December 6, 2012

    Report

    Report Number
    3003768277-2012-00085
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 30, 2012
    Manufacturer
    PHILIPS HEALTHCARE - BEST NETHERLANDS
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. RESULTS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE TRYING TO DRIVE UP THE MONITOR SUSPENSION, THE SUSPENSION DROPPED ONTO THE PATIENT TABLE UNCONTROLLABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI, MBQ IZI PHILIPS HEALTHCARE - BEST NETHERLANDS 722010

    Patients

    Seq Age Sex Outcome Treatment
    1