BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFICIA DFM100

    MDR report key: 18223530 · Received November 28, 2023

    Report

    Report Number
    3030677-2023-04669
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    November 6, 2023
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FSE CONFIRMED NO PATIENT INVOLVED, USER FOUND THE ISSUE WHEN PERFORMING DAILY CHECK ON THE DEVICE. THE USER TRIES TO DO THE OPERATIONAL TEST WHEN ONE OF THE CABLES WAS LOSE, SO THE TEST FAILED. AFTER A FEW HOURS A NEW USER TRIED THE TEST AFTER CONNECTING AGAIN THE CABLES, THIS TIME WITH NO PROBLEMS. AT THE TIME OF THE VISIT THE DEVICE WAS FULLY FUNCTIONAL. FSE REVIEWED ERROR LOG AND IT IS DETECTED THAT THE CABLES WERE LOOSE AT THE TIME THE USER ATTEMPTED THE TEST, A REVIEW IS CARRIED OUT AND THE CONDITION IS CORRECTED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

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

    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 WHEN USING THE DEFIBRILLATOR, IT GIVES THE CAPTION "DEFIBRILLATOR DISABLED". THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORTED PATIENT IMPACT / INJURY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WHEN USING DEVICE GIVES THE CAPTION "DEFIBRILLATOR DISABLED" . DEVICE WAS IN CLINICAL USE BUT NO REPORTED ADVERSE EVENT. IN A CONSERVATIVE ASSESSMENT OF THE RECORD, THE REPORTED EVENT WILL BE CONSIDERED A SERIOUS INJURY BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED AND OR DELAYED AND MAY HAVE LED TO A DETERIORATION IN THE STATE OF THE HEALTH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545564 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown