BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MFRX- EMS DEFIBRILLATOR

    MDR report key: 3761110 · Received December 31, 2013

    Report

    Report Number
    1218950-2013-06844
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Report Date
    December 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER STATES THE DEVICE FAILED OPCHECK WITH CHARGE BUTTON FAILURE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682947 HEARTSTART MFRX- EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1