BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2241456 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02309
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED UNABLE TO ACQUIRE 12 LEAD ECG. THERE WAS NO REPORTED ADVERSE PT IMPACT. A THIRD PARTY FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE PROBLEM WAS THE BLOCK CONNECTOR ECG. THE BLOCK CONNECTOR ECG WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO USE. WE WILL CONSIDER THIS A MALFUNCTION OF THE BLOCK CONNECTOR ECG WHERE 12 LEAD ECG COULD NOT BE ACQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNABLE TO ACQUIRE 12 LEAD ECG. THERE WAS NO REPORTED ADVERSE PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1