BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1934576 · Received December 3, 2010

    Report

    Report Number
    1218950-2010-02467
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 18, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT WHEN USING THIS DEFIBRILLATOR IN THE AED MODE, ARTIFACT PREVENTED INTERPRETATION OF THE RHYTHM. THERE WAS NO NEGATIVE IMPACT TO THE PT. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO TREAT THE PT. 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 WHEN USING THIS DEFIBRILLATOR IN THE AED MODE, ARTIFACT PREVENTED INTERPRETATION OF THE RHYTHM. THERE WAS NO NEGATIVE IMPACT TO THE PT. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO TREAT THE PT.

    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