BEUDAMED
    FDA Adverse Event Death Summary report: N

    EFFICIA DFM100 DEFIBRILLATOR/MONITOR

    MDR report key: 12808145 · Received November 13, 2021

    Report

    Report Number
    3030677-2021-15567
    Event Type
    Death
    Date Received
    November 13, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 12, 2021
    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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ((B)(6) 30TH.AUG.-2022) PARENT (B)(4) HAS BEEN RE-IDENTIFIED AS A DUPLICATE OF (B)(4) AND HAS BEEN PROCESSED ACCORDINGLY. PLEASE REFER TO ITS CHILD PR#1518422 WITH RECEIVED MND NO.:(B)(4) AND IT'S FOLLOW UP REPORT WITH RECEIVED MND NO.: (B)(4) FOR THE FULL INVESTIGATION OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THERE WAS A WHITE SCREEN ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THERE WAS A WHITE SCREEN ISSUE. 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
    1706453 EFFICIA DFM100 DEFIBRILLATOR/MONITOR XL+ DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown