BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3063203 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01082
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE FAILED TO ACQUIRE AN ECG WAVEFORM. IT WAS LATER DETERMINE THE ISSUE INVOLVED LEADS ECG. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE AND ACCESSORIES WERE SENT TO THE PHILIPS BENCH FOR EVALUATION. THE REPORTED SYMPTOMS COULD NOT BE REPRODUCED. EVENTS IN THE DEVICE LOGGED SHOWED LEADS ON/LEADS OFF MESSAGING. NOTE THAT THERE ARE MANY FACTORS THAT INFLUENCE THE QUALITY OF THE LEADS ECG WAVEFORM, INCLUDING BRAND AND QUALITY OF MONITORING ELECTRODES, SKIN PREP, AND PT MOVEMENT. THE REPORTED SYMPTOMS COULD NOT BE REPRODUCED AND WE ARE THEREFORE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOMS. PER THE DISCRETION OF THE REPAIR TECHNICIAN AS PROACTIVE PREVENTIVE MAINTENANCE THE ECG CONNECTOR, LEAD SET AND TRUNK CABLE WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO ACQUIRE AN ECG WAVEFORM. IT WAS LATER DETERMINE THE ISSUE INVOLVED LEADS ECG. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124841 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1