BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 18731463 · Received February 19, 2024

    Report

    Report Number
    3030677-2024-00654
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 19, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) AND PHILIPS PRODUCT SUPPORT ENGINEER (PSE) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 DEFIBRILLATOR INDICATING THAT THE CO2 DOES NOT COMPLY WITH THE LIMITS OF ELECTRICAL SAFETY UPON MAINTENANCE AND TESTING. THE EVENT WAS OUTSIDE OF USE AND THERE WAS NO REPORTED PATIENT NOR USER HARM. AVAILABLE DETAILS INDICATE THAT UPON PERFORMING ELECTRICAL TESTS, THE DEVICE'S ELECTRICAL CURRENTS (¿DFM100 WITH THE CO2 SOCKET¿) ARE EXCEEDING THE PERMISSIBLE LIMIT OF 5000 A. ADDITIONALLY, ¿THE USER MANUAL EDITION 2.0 (PAGE 198) STATES THAT THE CO2 SOCKET HAS A PATIENT INSULATION OF TYPE BF (BODY FLOATING). THIS OCCURRED AS A RESULT OF THE CUSTOMER PERFORMING MAINTENANCE CHECK, WHICH INCLUDES CHECKING THE ELECTRICAL SAFETY OF ALL APPLIED PARTS. REMOTE SERVICE WAS PROVIDED, THE CUSTOMER WAS INFORMED THAT IN THE CURRENT DFM100 SERVICE MANUAL, THE TEST SCHEMATIC DIAGRAM IS CITED IN STANDARD (IEC62353 AND IEC60601) TO PROVIDE THE BASIC TESTING PRINCIPLES. FROM DESIGN PERSPECTIVE, DFM100 DOES NOT HAVE THE ISOLATION DESIGN FOR ETCO2 SOCKET ON DEVICE BECAUSE APPLICATION PART IS OUT OF DEVICE. SO, DIRECTLY TESTING THE SOCKET WITHOUT APPLICATION PART (WHICH IS THE EXTERNAL ETCO2 MODULE) CONNECT TO DEVICE IS NOT A PROPER TEST METHOD AND THE TEST RESULT WILL DEFINITELY BE FAILED. THE CUSTOMER WAS ADDITIONALLY INFORMED THAT THE SOCKET IS NOT AN APPLIED PART HERE BUT THE ACCESSORIES TO BE CONNECTED ARE DECLARED AS AN APPLIED PART. AND SINCE BOTH CONNECTABLE ACCESSORIES ARE CLASSIFIED ACCORDING TO BF, IT IS PERMITTED TO DECLARE THE BF ON THE SOCKET, REGARDLESS OF WHETHER THE SOCKET IS AN APPLIED PART OR NOT. CUSTOMER REQUEST DOCUMENTATION THAT BOTH THE M2741A AND M2501A HAVE BEEN APPROVED AS BF APPLIED PARTS. THE TÜV TEST REPORT CONFIRMED MODULES M2741A IS BF TYPE APPLICATION MODULES. M2501A (I.E. MAINSTREAM ETCO2 SENSOR) IS NOT EXISTING IN TÜV REPORT BECAUSE TÜV CONSIDERS M2501A IS IMPROBABLY CONTACTED THE PATIENT BODY UNDER NORMAL USE CONDITIONS. NO PATIENT CONNECTION, THEREFORE, BF-TYPE TEST AGAINST M2501A IS EXEMPTED TO EXECUTE. THE DEVICE OPERATIONS AND COMPONENT FUNCTIONS WERE REVIEWED WITH THE CUSTOMER. IT WAS DETERMINED THAT UPON PERFORMING THE ELECTRICAL TESTS, THE CUSTOMER WAS NOT TESTING THE DEVICE APPROPRIATELY TO TESTING STANDARDS. DFM100 MEETS IEC 60601-1 GUIDELINES AND LEAKAGE TESTING, IT IS CONFIRMED THE CUSTOMER IS NOT TESTING THE SAME WAY AS TUV DID IN STANDARDS TESTING. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS ATTRIBUTED TO USER ERROR. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE CUSTOMER WAS PROVIDED INFORMATION TO APPROPRIATELY PERFORM ELECTRICAL TEST TO STANDARDS TESTING. THE ELECTRICAL TEST FAILURE WAS ATTRIBUTED TOWARDS USER ERROR. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DFM100 WITH CO2 SOCKET EXCEEDS THE PERMISSIBLE LIMITS OF 5000¿A FOR PATIENT LEAKAGE CURRENT. THERE WAS NO REPORTED 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
    424403 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown