BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1874397 · Received October 12, 2010

    Report

    Report Number
    1218950-2010-01921
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Report Date
    September 15, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED 12-LEAD ECG V3 SIGNAL LOSS. THERE WAS NO PT IMPACT. THE UNIT WAS EVALUATED BY THE SITE BIOMED. THE SYMPTOM COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL TESTING. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. THE CAUSE OF THE MALFUNCTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12-LEAD ECGT V3 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