BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART XL

    MDR report key: 1748131 · Received June 29, 2010

    Report

    Report Number
    1218950-2010-01047
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 23, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOMER REPORTED THAT THEY GOT "NO SHOCK DELIVERED" MESSAGES TWO TIMES DURING A PT EVENT. THEY SWITCHED TO A DIFFERENT DEFIBRILLATOR TO CARE FOR THE PT. THE INVOLVED PT DIED. WE ARE STILL TRYING TO DETERMINE IF THE DEVICE PLAYED A ROLE IN THE PT OUTCOME. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THEY GOT "NO SHOCK DELIVERED" MESSAGES TWO TIMES DURING A PT EVENT. THEY SWITCHED TO A DIFFERENT DEFIBRILLATOR TO CARE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death