BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD10

    MDR report key: 2220334 · Received August 16, 2011

    Report

    Report Number
    3003768277-2011-00481
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCING A HEART ATTACK WAS BROUGHT IN TO PERFORM A STUDY. ANOTHER USER PRESSED THE STOP BUTTON BY MISTAKE AND THE SYSTEM WOULD NOT POWER BACK ON. THEY HAD TO PLACE THE PATIENT ON AN ARREST MONITOR. THE CUSTOMER REPORTED THAT THE PATIENT EVENTUALLY DIED, BUT IT WAS NOT DUE TO THE CV ALLURA SYSTEM NOT BEING AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI, MBQ IZI PHILIPS HEALTHCARE 722003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death