BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1882811 · Received October 22, 2010

    Report

    Report Number
    1218950-2010-02027
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE CUSTOMER DETERMINED THE CAUSE OF THE ISSUE TO BE THE LEADS ECG LEAD SET. THERE WAS NO REPORT OF PT IMPACT. PHILIPS SUPPLIES SENT THE CUSTOMER A REPLACEMENT ECG LEADS TRUNK CABLE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12-LEAD ECG SIGNAL LOSS.

    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