BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 17273345 · Received July 6, 2023

    Report

    Report Number
    3030677-2023-02693
    Event Type
    Malfunction
    Date Received
    July 6, 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

    UPDATE: THERAPY PCA WAS RETURNED TO FAILURE ANALYSIS LAB FOR FURTHER TESTS. 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 ABLE TO THE PADDLE IS DISCONNECTED. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER CALLED AND SPOKE WITH A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE DEVICE WAS EVALUATED BY THE CUSTOMER WITH ASSISTANCE FROM RSE. RSE CONFIRMED THAT THE THERAPY PCA WILL NEED REPLACEMENT. THE CUSTOMER HAS ORDERED REPLACEMENT THERAPY PCA TO RECTIFY MALFUNCTION. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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
    2015990 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown