BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100 DEFIBRILLATOR MONITOR

    MDR report key: 21415602 · Received February 19, 2025

    Report

    Report Number
    3030677-2025-000547
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    April 24, 2024
    Report Date
    February 19, 2025
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    UDI-DI
    00884838057975
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FAILURE ANALYSIS ENGINEER (FAE) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 DEFIBRILLATOR INDICATING THAT THE SOM PCA (SYSTEM ON MODULE PRINTED CIRCUIT ASSEMBLY) BOARD FAILED TO BOOT UP. THE SOM PCA WAS REPLACED TO RESOLVE THE ISSUE AND THE DEVICE WAS RETURNED TO SERVICE. THE DEFECTIVE DFM100 SOM PCA ASSY, PART NUMBER: 45356448905, AND SERIAL NUMBER: (B)(6) WAS RETURNED TO PHILIPS FOR FAILURE ANALYSIS. A VISUAL INSPECTION OF THE SOM PCA WAS PERFORMED FOR SIGNS OF WEAR, DAMAGE, CORROSION, OR MISSING COMPONENTS, AND NO ANOMALIES WERE FOUND. A FUNCTIONAL TEST WAS THEN PERFORMED WHERE THE SOM PCA WAS PLACED ON THE TEST FIXTURE, AND THE FIXTURE WAS TURNED ON WITH THE THERAPY KNOB SET TO MONITOR. THE UNIT POWERED UP TO A SPLASH SCREEN BOOT LOOP. THIS IS AN INDICATION OF A DEFECTIVE SOM PCA. THE SOM PCA FAILED TO BOOT UP, THE ALLEGED FAILURE WAS RECREATED DURING FAILURE ANALYSIS. THE DEFECTIVE PART HAS BEEN ARCHIVED. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO A DEFECTIVE SOM PCA. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. 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
    1294530 EFFICIA DFM100 DEFIBRILLATOR MONITOR DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199 00884838057975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown