BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 17756599 · Received September 15, 2023

    Report

    Report Number
    3030677-2023-03677
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 19, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATION TEAM, INCLUDING PERSONNEL FROM CHINA R&D AND MALAYSIA MARKETING, CONDUCTED AN ON-SITE INSPECTION OF THE DEVICE AND BATTERY. THEY FOUND THAT THE BATTERY IS A FAKE PHILIPS BATTERY. HOSPITAL SLIM RIVER PURCHASED IT FROM EDEGENTA CENTRAL HI-TECH, WHICH IS PART OF THE EDEGENTA CONSORTIUM. EDEGENTA CENTRAL HI-TECH PURCHASED THE BATTERY FROM A LOCAL COMPANY NAMED CELESTIAL, RATHER THAN FROM THE PHILIPS MALAYSIA DEALER UMEDIC. CELESTIAL IS UNABLE TO PROVIDE EVIDENCE OF WHERE THEY PURCHASED THE BATTERY. AFTER INVESTIGATION, WE CONSIDER THE FAKE PHILIPS BATTERY CAUSED FIRE DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER WAS USING A 3RD PARTY BATTERY IN THE DEVICE WHICH CAUSED THE DEVICE TO CATCH FIRE. 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
    1040811 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown