BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 8425450 · Received March 15, 2019

    Report

    Report Number
    1218950-2019-02072
    Event Type
    Injury
    Date Received
    March 15, 2019
    Report Date
    February 15, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PR 9043315 IS BEING CONSIDERED A DUPLICATE OF (B)(4). PLEASE REFER TO (B)(4) AND MDR 1218950-2019-01388 FOR DETAILS ON THE INVESTIGATION AND CONCLUSION OF THIS CASE. THIS MDR (ABOVE) CODED IDENTICAL TO MDR 1218950-2019-01388.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT AFTER CHARGING THE DEVICE TO 200J FOR A PATIENT IN VENTRICULAR TACHYCARDIA (VT), THE DEVICE GAVE A MESSAGE INDICATING THE SHOCK WAS CANCELLED. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR AND THE SAME THING HAPPENED. THIS COMPLAINT DOCUMENTS THE FIRST DEFIBRILLATOR USED. (B)(4) DOCUMENTS THE FIRST DEFIBRILLATOR USED. THE INVOLVED PATIENT WAS REPORTED TO BE IN VENTRICULAR TACHYCARDIA (VT). THE OUTCOME OF THE PATIENT IS NOT YET KNOWN. THIS IS BEING DOCUMENTED AS A SERIOUS INJURY AS THE PATIENT WAS IN VT. PHILIPS HAS REQUESTED ADDITIONAL INFORMATION. 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 · 1

    IT WAS REPORTED TO PHILIPS THAT AFTER CHARGING THE DEVICE TO 200J FOR A PATIENT IN VENTRICULAR TACHYCARDIA (VT), THE DEVICE GAVE A MESSAGE INDICATING THE SHOCK WAS CANCELLED. THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR AND THE SAME THING HAPPENED. THIS COMPLAINT DOCUMENTS THE FIRST DEFIBRILLATOR USED. PR# 9043316 DOCUMENTS THE SECOND DEFIBRILLATOR USED. THE INVOLVED PATIENT WAS REPORTED TO BE IN VENTRICULAR TACHYCARDIA (VT). THE OUTCOME OF THE PATIENT IS NOT KNOWN. THIS IS BEING DOCUMENTED AS A SERIOUS INJURY AS THE PATIENT WAS IN VT. 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
    218291 HEARTSTART XL+ DEFIBRILLATOR/MONITOR XL+ DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1