BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 19017538 · Received April 2, 2024

    Report

    Report Number
    3030677-2024-01205
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 7, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A DUPLICATE SERVICE ORDER WAS FOUND IN THE QCM TRACKWISE DATABASE OR SOURCE SYSTEM. THIS DEVICE/ SERIAL# SYMPTOM HAS ALSO BEEN ALLEGED IN (B)(4). (B)(4) IS BEING CONSIDERED A DUPLICATE (B)(4) AS THE SERIAL NUMBERS ARE THE SAME AND THE EVENT WAS REPORTED THROUGH TWO DIFFERENT SALESFORCE CASES. SALESFORCE CASE (B)(4) WAS CLOSED WITH THE CLOSED CASE COMMENT OF "DUPLICATED, REFER TO (B)(4)" CONFIRMING THE DUPLICATION. AS SUCH, THIS FILE ((B)(4)) WILL BE CLOSED AS A DUPLICATE AND ALL RELEVANT INFORMATION PERTAINING TO THE INVESTIGATION ASSOCIATED WITH THIS EVENT WILL BE HOUSED IN (B)(4) (EMDR REPORT: MFR REPORT NUMBER: 3030677-2024-01297).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE DEFIBRILLATOR INDICATING THAT THE DEVICE FAILED ESA TEST. 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
    1665706 EFFICIA DFM100 XL+DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown