BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 17376176 · Received July 24, 2023

    Report

    Report Number
    3030677-2023-02928
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 27, 2023
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED AND SPOKE WITH A PHILIPS REPRESENTATIVE. THE CUSTOMER REQUESTED JUST A REPLACEMENT THERAPY PCA MODULE WITH NO ENGINEER EVALUATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. 16/NOV/2023 UPDATE: FA RESULT: THIS PCA WAS RETURNED "ECG FAILURE". THIS WAS NOT VERIFIED IN LAB TESTING. THE THERAPY PCA PASSED ALL TESTS DURING OP CHECK AND PERFORMED AS EXPECTED. THEREFORE, THERE IS NO FAULT FOUND (NFF) WITH THIS THERAPY BOARD.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT INDICATES THAT DEVICE HAD ECG FAILURE. DEVICE WAS NOT IN USE AT TIME OF EVENT. 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
    749420 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown