BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2081643 · Received April 28, 2011

    Report

    Report Number
    1218950-2011-01191
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT USE OF THE QCPR METER RESULTED IN A LACERATION ON THE PATIENT'S CHEST. THE INVOLVED PATIENT DIED BUT THERE IS NO ALLEGATION OF ANY INABILITY OF THE DEVICE TO DELIVER THERAPY. STAFF DELIVERED CPR AND ONE SHOCK VIA A SEPARATE AED DEVICE. THE INITIAL MRX RHYTHM WAS ASYSTOLE WITH RANDOM NON-CAPTURED PACER SPIKES PER THE PARAMEDIC. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT USE OF THE QCPR METER RESULTED IN A LACERATION ON THE PATIENT'S CHEST.

    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