BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 16877616 · Received May 5, 2023

    Report

    Report Number
    3030677-2023-01891
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 10, 2023
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 INDICATING, THAT WHEN MONITORING WITH THE ECG, "F FAILURE" MESSAGE APPEARS. THERE WAS REPORTEDLY, NO PATIENT INVOLVEMENT. THE FSE EVALUATED THE DEVICE ON SITE. IT WAS DETERMINED, THIS WAS A MALFUNCTION OF THE CABLE FOR IXR AND ECG/RESP CABLES. THE CUSTOMER REPLACED THE DEFECTIVE CABLES RESOLVING THE REPORTED ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. 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
    1670672 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown