BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX-EMX DEFIBRILLATOR

    MDR report key: 1962505 · Received January 6, 2011

    Report

    Report Number
    1218950-2011-00035
    Event Type
    Death
    Date Received
    January 6, 2011
    Date of Event
    November 27, 2010
    Report Date
    December 9, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THE DEFIB PADS WOULD NOT CONNECT TO THE THERAPY CABLE DURING A PATIENT EVENT. THE USERS SWITCHED TO ANOTHER DEVICE TO TREAT THE PATIENT. THE INVOLVED PATIENT DIED, BUT THE CUSTOMER HAS STATED THAT THE DEVICE WAS NOT A FACTOR IN THE PATIENT OUTCOME AS THEY WERE ABLE TO TREAT WITH THE OTHER DEVICE. 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 THE DEFIB PADS WOULD NOT CONNECT TO THE THERAPY CABLE DURING A PATIENT EVENT. THE USERS SWITCHED TO ANOTHER DEVICE TO TREAT THE PATIENT. THE INVOLVED PATIENT DIED, BUT THE CUSTOMER HAS STATED THAT THE DEVICE WAS NOT A FACTOR IN THE PATIENT OUTCOME AS THEY WERE ABLE TO TREAT WITH THE OTHER DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1