BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 16330629 · Received February 8, 2023

    Report

    Report Number
    3030677-2023-00591
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    December 21, 2022
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AVAILABLE DETAILS INDICATE THAT THE DEVICE'S PNI CLAMP WITH WORN VELCRO . DETAILS PROVIDED IN AN UPDATE FROM TAN EMAIL INDICATE THAT THE EQUIPMENT WAS EVALUATED BY A TECHNICIAN FROM THE PHILIPS LOCAL REPRESENTATIVE, AND FOUND WORN PNI CLAMP. THIS PART WAS EASY CARE CUFF, 1 HOSE, ADULT (1) WAS REPLACED AND THE DEVICE WAS SUCCESSFULLY RETURNED TO SERVICE. THE FAULTY COMPONENT WAS REPLACED AND FUNCTIONAL TESTS WERE PERFORMED AND THE DEVICE WAS RETURNED TO SERVICE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DEVICE HAS MISSING OR DAMAGED EXTERNAL PART.THERE¿S 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
    1356177 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown