BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 18648064 · Received February 6, 2024

    Report

    Report Number
    3030677-2024-00466
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 15, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA DFM100 DEFIBRILLATOR MONITOR INDICATING ECG PADS, CALIBRATION FAIL, PLL TIME FAIL & THERAPY FAILURE. THERE¿S NO REPORTED 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
    2087185 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown