BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1961488 · Received January 10, 2011

    Report

    Report Number
    1218950-2011-00078
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    December 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE DID NOT GIVE A SHOCK ADVISORY DECISION AS EXPECTED WHILE BEING USED ON A PT IN THE AED MODE. THE CUSTOMER STATED THAT DEVICE BEHAVIOR DID NOT NEGATIVELY AFFECT PT OUTCOME. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT GIVE A SHOCK ADVISORY DECISION AS EXPECTED WHILE BEING USED ON A PT IN THE AED MODE. THE CUSTOMER STATED THAT DEVICE BEHAVIOR DID NOT NEGATIVELY AFFECT PT OUTCOME.

    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