BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1671937 · Received April 29, 2010

    Report

    Report Number
    1218950-2010-00612
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOMER REPORTED THAT DURING A PT EVENT THE PARAMEDICS WERE NOT SURE THAT ENERGY HAD BEEN DELIVERED TO THE PT. THE DEVICE WAS NOT A FACTOR IN THE PT OUTCOME. THE DATE OF THIS EVENT, THE DEVICE PASSED OPERATIONAL CHECKS DONE BY THE CUSTOMER. ADDITIONALLY, THE PARAMEDICS REVIEWED THE EVENT FILES AND CONFIRMED THAT ALL ENERGY DELIVERIES HAD BEEN COMPLETED. THERE WAS NO MALFUNCTION OF THE DEVICE. THIS IS A USER MISUNDERSTANDING.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT DURING A PT EVENT THE PARAMEDICS WERE NOT SURE THAT ENERGY HAD BEEN DELIVERED TO THE PT. THE DEVICE WAS NOT A FACTOR IN THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death