BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFICIA DFM100

    MDR report key: 18197331 · Received November 23, 2023

    Report

    Report Number
    3030677-2023-04639
    Event Type
    Injury
    Date Received
    November 23, 2023
    Date of Event
    October 26, 2023
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS FOUND DUPLICATE OF PR 4003304 AS PER INVESTIGATOR¿S CONFIRMATION. THUS PLEASE REFER TO EMDR REPORT(MFR REPORT NUMBER: 3030677-2023-04628) FOR FURTHER DETAILS.

    Additional Manufacturer Narrative · 0

    REPORTING ADDRESS LINE 1: (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE DEFIBRILLATOR/MONITOR INDICATING THAT THE DEVICE WAS UNABLE TO DISCHARGE WHILE IN USE. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED. 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
    223339 EFFICIA DFM100 XL+DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening