BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD20

    MDR report key: 2499785 · Received March 20, 2012

    Report

    Report Number
    3003768277-2012-00022
    Event Type
    Death
    Date Received
    March 20, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 12, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K033737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WIRELESS FOOTSWITCH FAILED TO OPERATE DURING CRITICAL PT CARE. SYSTEM WAS UNABLE TO PROVIDE FLUOROSCOPIC GUIDANCE WHEN REQUESTED. PT FAILED TO RECOVER FROM CORONARY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI, MBQ IZI PHILIPS HEALTHCARE 722012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death