BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRIS ALLURA 15-12 (MONO)

    MDR report key: 3426507 · Received October 17, 2013

    Report

    Report Number
    3003768277-2013-00045
    Event Type
    Death
    Date Received
    October 17, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 4, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT THE SYSTEM FAILED BEFORE THE BEGINNING OF THE PROCEDURE OF A PT WHICH HAD A HEART ATTACK. THEY HAD TO TRANSFER A PT TO ANOTHER HOSPITAL BECAUSE THEY WERE NOT ABLE TO TAKE CARE OF THE PT DUE TO THE FACT THAT INTEGRIS ALLURA FD12/15 WAS OUT OF ORDER. DURING THE TRANSFER PROCESS, THE PT DIED. THE DELAY IN THE TREATMENT DUE TO THE TRANSFER TO ANOTHER HOSPITAL HAS PROBABLY BEEN THE CAUSE OF THE INCIDENT ACCORDING TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533135 INTEGRIS ALLURA 15-12 (MONO) IZI PHILIPS HEALTHCARE 722043

    Patients

    Seq Age Sex Outcome Treatment
    1 Death