BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 15273522 · Received August 23, 2022

    Report

    Report Number
    3030677-2022-04053
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    August 17, 2022
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING ADDRESS STATE: (B)(6). REPORTING ADDRESS POSTAL: (B)(6). REPORTING INSTITUTION PHONE: (B)(6). REPORTER PHONE: (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS PCA WAS RETURNED TO PHILIPS BENCH REPAIR CENTER "REQUEST A QUOTE FOR INTERVENTION". 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

    IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER REQUEST A QUOTATION FOR THERAPY PCA AND ON-SITE SERVICE. THERE WAS NO PATIENT INVOLVEMENT. 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
    2375281 EFFICIA DFM100 XL+DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown