BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 15593410 · Received October 13, 2022

    Report

    Report Number
    3030677-2022-04603
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 14, 2022
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    FA INVESTIGATION UPDATE. THIS PCA WAS RETURNED "WHEN EQUIPMENT IS STARTED A "POWER TEST ERROR" MESSAGE APPEARS-". 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. DATA GENERATED BY THIS INVESTIGATION WILL BE LOGGED FOR TRENDING ANALYSIS.

    Additional Manufacturer Narrative · 0

    THIS PCA WAS RETURNED "WHEN EQUIPMENT IS STARTED A "POWER TEST ERROR" MESSAGE APPEARS-". 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. DATA GENERATED BY THIS INVESTIGATION WILL BE LOGGED FOR TRENDING ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WHEN STARTING UP, "POWER TEST ERROR" IS DISPLAYED AND IT CANNOT BE USED. 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

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS LAB SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 DEFIBRILLATOR INDICATING THAT WHEN IT STARTED, A "POWER TEST ERROR" WAS DISPLAYED AND IT COULD NOT BE USED. THERE WAS REPORTEDLY 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.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY LOCAL PHILIPS CUSTOMER SUPPORT PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM.¿ PHILIPS RECEIVED A COMPLAINT ON THE PHILIPS DFM100 DEFIBRILLATOR INDICATING THAT THE DEVICE ISSUED POWER TEST ERRORS THAT PREVENTED THE DEVICE FROM POWERING ON NORMALLY. 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
    1972005 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown