BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2943507 · Received January 9, 2013

    Report

    Report Number
    1218950-2013-00089
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 19, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN ISSUE WITH THE 12 LEAD CABLE. IT WAS LATER CONFIRMED THE CUSTOMER WAS EXPERIENCING INTERMITTENT ACQUISITION OF THE 12 LEAD ECG. THERE IS NO REPORTED NEGATIVE PT IMPACT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THE 12 LEAD CABLE. THERE IS NO REPORTED NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13123 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1