BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX- EMS DEFIBRILLATOR

    MDR report key: 3031263 · Received March 5, 2013

    Report

    Report Number
    1218950-2013-00768
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT THEY DISAGREED WITH A SHOCK ADVISORY DECISION GIVEN IN THE AED MODE. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THEY DISAGREED WITH A SHOCK ADVISORY DECISION GIVEN IN THE AED MODE. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94744 HEARTSTART MRX- EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1