BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 17668433 · Received September 1, 2023

    Report

    Report Number
    3030677-2023-03446
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    February 23, 2023
    Report Date
    December 20, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HEALTHCARE DEMSTOCK REPORTED, DURING TRAINING EXERCISE, THERAPY PCA WAS DAMAGED AND THERE LEDS ON THE UI ARE LIT WHEN ON BATTER OR CONNECTED TO MAINS. THE FSE (FIELD SERVICE ENGINEER) ONSITE CHECKED AND CONFIRMED THE CAUSE OF THE REPORTED PROBLEM WAS DEFECTIVE THERAPY PCA AND THE PROCESSOR PCA. FSE REPLACED 453564489061 DFM100 ASSY THERAPY WAS REPLACED AND 453564489071 PROCESSOR PCA, THE DFM CABLE UI-PRO PCA 2.1 (453564844301) WAS REPLACED TO BE COMPATIBLE WITH THE NEW PCA. FSE RELOADED OPTIONS, SERIAL NUMBER, RELOADED SW 2.00.32. PERFORMANCE VERIFIED AND SAFETY TESTED. THIS DFM100 ASSY THERAPY S/N: (B)(6) WAS RETURNED. THIS "NO POWER LED'S" WAS NOT VERIFIED IN LAB TESTING. THE PCA FAILED THERAPY TESTING DUE TO A MISSING CONNECTION POINT AFTER REPAIR, THE DEVICE PASSED OP CHECK AND GENERAL TESTING. THIS PCA ¿ J18, MISSING. THIS DFM100 ASSY PROCESSOR WAS RETURNED. THIS "NO POWER LED'S" WAS NOT VERIFIED IN LAB TESTING. THE PCA PASSED ALL TESTS DURING OP CHECK AND GENERAL TESTING. THIS DFM100 ASSY PROCESSOR IS NO FAILURE FOUND. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    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 DFM100 INDICATING THAT THE THERE WAS NO POWER LEDS. THERE WAS NO 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.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS HEALTHCARE DEMSTOCK AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE DFM100 INDICATING THAT THE THERE WAS NO POWER LEDS, DAMAGED DURING TRAINING COURSE. THERE WAS NO 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.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS HEALTHCARE DEMSTOCK AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE DFM100 INDICATING THAT THE THERE WAS NO POWER LEDS, DAMAGED DURING TRAINING COURSE. THERE WAS NO 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
    1263222 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown