BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 16493594 · Received March 7, 2023

    Report

    Report Number
    3030677-2023-00961
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 7, 2023
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER INFORMATION: (B)(6). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS CASE IS FOUND DUPLICATE OF PR 2953227 AS PER INVESTIGATOR¿S CONFIRMATION. THUS PLEASE REFER TO EMDR REPORT(MFR REPORT NUMBER: 3030677-2023-00787) FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ERROR. RELATED PATIENT INVOLVEMENT INFORMATION IS CURRENTLY UNKNOWN, AND REQUEST HAS BEEN SENT OUT FOR SUCH INFORMATION. HOWEVER, THERE IS NO ADVERSE EVENT. 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
    659686 EFFICIA DFM100 XL+DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown