BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1821584 · Received August 27, 2010

    Report

    Report Number
    1218950-2010-01422
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THIS DEFIBRILLATOR FAILED TO CHARGE TWICE. THE USERS CYCLED THE POWER AND DELIVERED ONE SHOCK TO THE PT THAT CONVERTED THE PT RHYTHM. NO FURTHER THERAPY WAS REQUIRED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW- UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THIS DEFIBRILLATOR FAILED TO CHARGE TWICE. THE USERS CYCLED THE POWER AND DELIVERED ONE SHOCK TO THE PT THAT CONVERTED THE PT RHYTHM. NO FURTHER THERAPY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1