BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2041435 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00604
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED 12-LEAD ECG SIGNAL LOSS. THERE WAS NO REPORT OF PT IMPACT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THAT ONLY WAVEFORM LEAD I DISPLAYED. THE ISSUE WAS RESOLVED BY REPLACING THE LEADS ECG TRUNK CABLE.

    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 9C

    Patients

    Seq Age Sex Outcome Treatment
    1