BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFBRILLATOR

    MDR report key: 2140634 · Received June 16, 2011

    Report

    Report Number
    1218950-2011-01715
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A VS LEADS ECG FAILURE. THERE WAS NO REPORTED ADVERSE PT IMPACT. PHILIPS EVALUATED THE DEVICE AND WAS UNABLE TO RECREATE THE V3 LEADS ERROR. PHILIPS REVIEWED THE PT EVENT FILES AND CONFIRMED THE REPORTED SYMPTOMS. THE MODULE WAS INSPECTED AND FOUND TO HAVE CORROSION. THE MEASUREMENT MODULE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A V3 LEADS ECG FAILURE. THERE WAS NO REPORTED ADVERSE PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1