BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1913994 · Received November 19, 2010

    Report

    Report Number
    1218950-2010-02322
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    October 21, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED FAILURE TO CAPTURE 12-LEAD ECG. THERE WAS NO REPORT OF PT IMPACT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. THE FSE CONFIRMED THE SYMPTOM AND RESOLVED THE MALFUNCTION BY REPLACING THE PRINTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILURE TO CAPTURE 12-LEADS ECG. THERE WAS NO REPORT OF PT IMPACT.

    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