BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFICIA DFM100

    MDR report key: 19879735 · Received August 1, 2024

    Report

    Report Number
    3030677-2024-02717
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 28, 2024
    Report Date
    August 14, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE ENGINEER (FSE) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE DFM100 DEVICE INDICATING THE FAILURE TO DISCHARGE NORMALLY. DEFIBRILLATORS ARE LIFE-SAVING DEVICES; FAILURE OF THE DEVICE TO PERFORM AS INTENDED MAY RESULT IN A LIFE-THREATENING SITUATION. IN A CONSERVATIVE ASSESSMENT OF THE AVAILABLE INFORMATION, THIS EVENT WILL BE CONSIDERED A SERIOUS INJURY DUE TO THE SERIOUS DETERIORATION OF HEALTH THAT MAY RESULT FROM A DELAY OR FAILURE TO SHOCK. THE EFFICIA DFM100 DEFIBRILLATOR, MODEL# 866199, IS SUBSTANTIALLY SIMILAR TO THE HEARTSTART XL+ DEFIBRILLATOR (MODEL # 861290) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL # 861290.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING THE RESCUE OF PATIENT, THE DISCHARGE OF THE DEVICE WAS SUSPENDED AND COULD NOT DISCHARGE NORMALLY. THE DEALER THEN RUSHED TO THE HOSPITAL AND CONDUCTED A SELF-INSPECTION ON THE TWO DEVICES. THE SELF-INSPECTION REPORTS SHOWED NO ISSUES. THEY ALSO COMMUNICATED WITH EACH OTHER ABOUT THE OPERATING METHODS AND PATIENT CONDITIONS AND FOUND NO ABNORMALITIES. THE CUSTOMER SUCCESSFULLY RESCUED THE PATIENT USING OTHER DEFIBRILLATOR. DEFIBRILLATORS ARE LIFE-SAVING DEVICES; FAILURE OF THE DEVICE TO PERFORM AS INTENDED MAY RESULT IN A LIFE-THREATENING SITUATION. IN A CONSERVATIVE ASSESSMENT OF THE AVAILABLE INFORMATION, THIS EVENT WILL BE CONSIDERED A SERIOUS INJURY DUE TO THE SERIOUS DETERIORATION OF HEALTH THAT MAY RESULT FROM A DELAY OR FAILURE TO SHOCK. THE EFFICIA DFM100 DEFIBRILLATOR, MODEL# 866199, IS SUBSTANTIALLY SIMILAR TO THE HEARTSTART XL+ DEFIBRILLATOR (MODEL # 861290) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL # 861290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165071 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening