BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 18723280 · Received February 16, 2024

    Report

    Report Number
    3030677-2024-00623
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 24, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERIAL NUMBER SEARCH OF QCM TRACKWISE AND THE SOURCE SYSTEM FOUND A POTENTIAL DUPLICATE OR PREVIOUS CASES ASSOCIATED WITH THIS DEVICE. UPON REVIEW, IT IS DETERMINED THIS CASE IS A DUPLICATE OF PR (B)(4)// CFM CASE / NMPA# (B)(4). SERIAL NUMBER (B)(6), EVENT DATE (24JAN/2024) AND REPORTED ISSUE ("DEVICE DID NOT SHOW WAVEFORM"/"ECG CANNOT BE DETECTED") ARE THE SAME. SEE PR (B)(4) WITH RECEIVED REFERENCE NO.: (B)(4) FOR COMPLETE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REPORTING ADDRESS: (B)(6).

    Description of Event or Problem · 0

    A SERIAL NUMBER SEARCH OF QCM TRACKWISE AND THE SOURCE SYSTEM FOUND A POTENTIAL DUPLICATE OR PREVIOUS CASES ASSOCIATED WITH THIS DEVICE. UPON REVIEW, IT IS DETERMINED THIS CASE IS A DUPLICATE OF PR (B)(4)// CFM CASE / NMPA# (B)(4). SERIAL NUMBER (B0(6)), EVENT DATE (24JAN/2024) AND REPORTED ISSUE ("DEVICE DID NOT SHOW WAVEFORM"/"ECG CANNOT BE DETECTED") ARE THE SAME. SEE PR (B)(4) FOR COMPLETE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE ECG CANNOT BE DETECTED. THERE WAS NO REPORTED PATIENT IMPACT OR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417278 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown