BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 15309109 · Received August 29, 2022

    Report

    Report Number
    3030677-2022-04131
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 25, 2022
    Report Date
    February 26, 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
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER INFORMATION: (B)(6).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER JUST WANTED TO ORDER A PROCESSOR PRINTED CIRCUIT ASSEMBLY PCA. THE PROCESSOR PCA WAS SENT TO THE CUSTOMER. THE PROCESSOR PRINTED CIRCUIT ASSEMBLY WITH PART NUMBER 453564489071 AND SERIAL NUMBER (B)(6) WAS RETURNED TO PHILIPS FOR FAILURE ANALYSIS. ALL TESTS PASSED AND ALL FUNCTIONALITY WAS VERIFIED. THE ROOT CAUSE OF THE DEVICE FAILURE IS UNKNOWN. THE DEVICE REMAINS AT THE CUSTOMER SIDE, AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THIS PCA WAS RETURNED WITH A SUPPOSED ECG PROBLEM. THIS WAS NOT VERIFIED IN LAB TESTING. THE PROCESSOR PCA PASSED ALL TESTS DURING OPERATIONAL CHECK AND PERFORMED AS EXPECTED. THEREFORE, THERE¿S NO FAULT FOUND (NFF) WITH THIS PROCESSOR PCA. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE DATA ENTERED INTO THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. THE PROCESSOR PCA PASSED ALL TESTS AND PERFORMED AS EXPECTED. THEREFORE, THERE IS A NO FAULT FOUND (NFF) SITUATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAS ECG PROBLEM. 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.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 INDICATING THE DEVICE HAS AN ECG PROBLEM. 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
    2100719 EFFICIA DFM100 XL+DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199 00884838057975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown