BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1662575 · Received April 16, 2010

    Report

    Report Number
    1218950-2010-00538
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 18, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER A SHOCK AS EXPECTED. THE CUSTOMER STATED THAT THE RELATIONSHIP BETWEEN THE DEVICE BEHAVIOR AND PT OUTCOME WAS UNK AT THIS TIME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER A SHOCK AS EXPECTED. THE CUSTOMER STATED THAT THE RELATIONSHIP BETWEEN THE DEVICE BEHAVIOR AND PT OUTCOME WAS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ AGILENT TECHNOLOGIES, INC. M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death