BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1851955 · Received September 23, 2010

    Report

    Report Number
    1218950-2010-01705
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    August 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED INTERMITTENT 12-LEAD ANALYSIS FOR THIS DEVICE. THERE WAS NO PATIENT IMPACT. THE HOSPITAL BIOMEDICAL ENGINEER EVALUATED THE DEVICE, BUT COULD NOT REPRODUCE THE PROBLEM. THE DEVICE, TRUNK CABLE AND LEAD SET WERE RETURNED TO PHILIPS AND THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTING. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION, BUT WE ARE UNABLE TO DETERMINE THE CAUSE, AS THE SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED INTERMITTENT 12-LEAD ANALYSIS FOR THIS DEVICE. THERE WAS NO PATIENT 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