BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1920575 · Received December 8, 2010

    Report

    Report Number
    1218950-2010-02485
    Event Type
    Death
    Date Received
    December 8, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED A POSSIBLE FAILURE TO DISCHARGE INVOLVING THIS DEFIBRILLATOR. THE PT RECEIVED TWO SHOCKS BUT DID NOT HAVE A MUSCULAR RESPONSE TO THE SHOCKS. THE INVOLVED PT DIED BUT THE CUSTOMER HAS STATED THAT THE DEVICE WAS NOT A FACTOR IN THE PT OUTCOME AS THE PT WAS ASYSTOLIC UPON ARRIVAL OF EMS WITH A DOWNTIME OF UNK DURATION. THE DEVICE IS BEING RETURNED TO PHILIPS FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED A POSSIBLE FAILURE TO DISCHARGE INVOLVING THIS DEFIBRILLATOR. THE PT RECEIVED TWO SHOCKS BUT DID NOT HAVE A MUSCULAR RESPONSE TO THE SHOCKS. THE INVOLVED PT DIED BUT THE CUSTOMER HAS STATED THAT THE DEVICE WAS NOT A FACTOR IN THE PT OUTCOME AS THE PT WAS ASYSTOLIC UPON ARRIVAL OF EMS WITH A DOWNTIME OF UNK DURATION. THE DEVICE IS BEING RETURNED TO PHILIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1