BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1961433 · Received January 10, 2011

    Report

    Report Number
    1218950-2011-00088
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    December 24, 2010
    Report Date
    January 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT WHILE TREATING A PT IN CARDIAC ARREST THEY GOT PADS ECG INTERFERENCE AND ARTIFACT THAT WAS CONSISTENT WITH 60 HZ INTERFERENCE. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO TREAT THE PT. THE INVOLVED PT DIED BUT THE CUSTOMER HAS STATED THAT THE DEVICE BEHAVIOR WAS NOT A FACTOR IN THE PT OUTCOME. A F/U REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT WHILE TREATING A PT IN CARDIAC ARREST, THEY GOT PADS ECG INTERFERENCE AND ARTIFACT THAT WAS CONSISTENT WITH 60 HZ INTERFERENCE. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO TREAT THE PT. THE INVOLVED PT DIED, BUT THE CUSTOMER HAS STATED THAT THE DEVICE BEHAVIOR 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 HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1