BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100 DEFIBRILLATOR/MONITOR

    MDR report key: 12613293 · Received October 12, 2021

    Report

    Report Number
    3030677-2021-14895
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    October 4, 2021
    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
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE ECG EQUIPMENT MALFUNCTION. DEVICE WAS IN CLINICAL USE AT TIME OF EVENT. HOWEVER, NO PATIENT HARM REPORTED. THERE WAS NO ADVERSE EVENT. 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.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE ECG EQUIPMENT MALFUNCTION. IT'S UNKNOWN WHETHER THERE'S PATIENT INVOLVEMENT, WAITING FOR GEF FEEDBACK. THERE WAS NO ADVERSE EVENT. 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
    1516432 EFFICIA DFM100 DEFIBRILLATOR/MONITOR XL+DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown