BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 14913157 · Received July 5, 2022

    Report

    Report Number
    3030677-2022-03329
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 28, 2022
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(6). PR#(B)(4) HAS BEEN IDENTIFIED AS A DUPLICATE OF PR#(B)(4)/CHILD RECORD PR#(B)(4) AND HAS BEEN PROCESSED ACCORDINGLY. PLEASE REFER TO PR#(B)(4)/CHILD RECORD PR#(B)(4) WITH RECEIVED MND NO.:(B)(4) FOR THE FULL INVESTIGATION OF THIS ISSUE.

    Additional Manufacturer Narrative · 0

    (WX 23RD.,SEPT.-2022) PR#2233232 HAS BEEN IDENTIFIED AS A DUPLICATE OF PR#1892277/CHILD RECORD PR#1926978 AND HAS BEEN PROCESSED ACCORDINGLY. PLEASE REFER TO PR#1892277/CHILD RECORD PR#1926978 WITH RECEIVED MND NO.:4AFF3CBB-E0C3-11EC-BEE2-000031D32FEF@HPP FOR THE FULL INVESTIGATION OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER REQUEST FOR A BENCH REPAIR DUE TO THE REASON THAT THE DEVICE WAS DROPPED AND DID NOT PASS THE OPERATION CONTROL TEST. 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
    1449858 EFFICIA DFM100 XL+ DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown