BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2192398 · Received July 26, 2011

    Report

    Report Number
    1218950-2011-02135
    Event Type
    Death
    Date Received
    July 26, 2011
    Report Date
    June 27, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT THE DEVICE WAS ANALYZING MORE FREQUENTLY THAN IT SHOULD IN THE AED MODE. THE INVOLVED PT DIED, BUT WE HAVE NOT YET CONFIRMED WHAT ROLE THE DEVICE BEHAVIOR PLAYED IN THE PT OUTCOME. WE ARE CONSIDERING THIS AS A MALFUNCTION BASED ON THE CUSTOMER REPORT ONLY. THIS COMPLAINT IS STILL BEING INVESTIGATED. 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 THE DEVICE WAS ANALYZING MORE FREQUENTLY THAN IT SHOULD IN THE AED MODE. THE INVOLVED PT DIED, BUT WE HAVE NOT YET CONFIRMED WHAT ROLE THE DEVICE BEHAVIOR PLAYED IN THE PT OUTCOME. WE ARE CONSIDERING THIS AS A MALFUNCTION BASED ON THE CUSTOMER REPORT ONLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1