BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMD DEFIBRILLATOR

    MDR report key: 4231749 · Received October 14, 2014

    Report

    Report Number
    1218950-2014-06121
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 13, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HEARTSTART MRX "ENTITLE" (ETCO2) IS BROKEN. IT IS PUSHED BACK INTO THE UNIT AND IT IS NOT FUNCTIONING. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650040 HEARTSTART MRX - EMD DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1