BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 21591644 · Received March 13, 2025

    Report

    Report Number
    3030677-2025-000816
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 24, 2025
    Report Date
    May 14, 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
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RETRACTED AS IT IS A DUPLICATE OF THE REPORT SUBMITTED ON MDR#3030677-2025-000815. PLEASE DISREGARD THIS REPORT.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE DEFIBRILLATOR INDICATING THAT PROCESSOR TO UI CABLE IS DEFECTIVE. 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
    1585806 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199 00884838057975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown