BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2488159 · Received March 7, 2012

    Report

    Report Number
    1218950-2012-00824
    Event Type
    Death
    Date Received
    March 7, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT THEY COULD NOT ACQUIRE A PADS ECG WAVEFORM DURING A PT EVENT. THEY SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER TREATMENT TO THE PT. THE INVOLVED PT DIED. 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 THEY COULD NOT ACQUIRE A PADS ECG WAVEFORM DURING A PT EVENT. THEY SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER TREATMENT TO THE PT. THE INVOLVED PT DIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death