BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1853743 · Received October 1, 2010

    Report

    Report Number
    1218950-2010-01816
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED 12-LEAD ECG FAILURE. THERE WAS NO REPORT OF PT IMPACT. THE CUSTOMER REPLACED THE ECG LEADS TRUNK CABLE TO RESOLVE THE ISSUE. BASED ON THE CUSTOMERS REPORT, WE WILL CONSIDER THIS TO HAVE BEEN A MALFUNCTION OF THE ECG LEADS TRUNK CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12-LEAD ECG FAILURE. 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