BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 11625562 · Received April 6, 2021

    Report

    Report Number
    3030677-2021-10737
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    February 25, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION, THIS CASE WAS DETERMINED TO BE A DUPLICATE RECORD; THE REPORTED PROBLEM AND RESULTS OF THE INVESTIGATION ARE CONTAINED IN MFR REPORT #3030677-2021-00554.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS CASE WAS DETERMINED THROUGH INVESTIGATION TO BE A DUPLICATE OF (B)(4). THE INVESTIGATION SUMMARY FROM (B)(4) IS AS FOLLOWS: THE CUSTOMER REPORTED THAT, ON ARRIVAL, THE RFU DISPLAYED AN HOURGLASS AND THE OPCHECK WAS COMPLETED SUCCESSFULLY. THE CUSTOMER REPORTED THAT THE DEVICE RESTARTED AFTER THEY BEGAN PACING AND, AFTER THE DEVICE RESTARTED, THERE WAS NO ECG WAVEFORM DISPLAYED. A PHILIPS CLINICIAN REVIEWED THE PATIENT EVENT FILE. THE DEVICE WAS POWERED ON INTO THE AED MODE AND DEFIBRILLATOR PADS WERE APPLIED. AFTER SOME INITIAL ARTIFACT, A ¿NO SHOCK ADVISED¿ DECISION WAS GENERATED. AT 1:08 ELAPSED TIME (ET) THE USERS SWITCHED TO THE MANUAL MODE, CHARGED TO 150J AND DELIVERED A SHOCK AT 1:18 ET. WHEN THE USERS SWITCHED INTO THE MANUAL MODE TO DELIVER THE SHOCK, THE PADS ECG WAVEFORM WAS NO LONGER DISPLAYED. A ¿CANNOT ANALYZE ECG¿ MESSAGE WAS GENERATED AND THE USERS THEN SWITCHED INTO THE PACER MODE. ECG LEADS WERE PLACED AT 2:53 ET, BUT NO ECG LEADS OR PADS ECG WAVEFORM WAS DISPLAYED. AT 3:07 ET THE USERS INITIATED DEMAND MODE PACING (70 PPM/30 MA). ONCE PACING WAS STARTED THERE WERE RAIL TO RAIL DEFLECTIONS DISPLAYED BUT WITHOUT AN UNDERLYING ECG WAVEFORM. AT 4:33 ET THE DEVICE RESTARTED WITH AN ASSOCIATED ¿DEVICE RESTARTED DUE TO ERROR¿ MESSAGE. PACING WAS INITIATED TWO MORE TIMES BY THE USERS AND EACH TIME THERE WAS THE SAME RAIL TO RAIL DEFLECTIONS WITHOUT AN UNDERLYING WAVEFORM. A PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND TRACED THE ISSUE TO THE PROCESSOR PCA. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE DEVICE LOGS AND IDENTIFIED A REBOOT DUE TO A HW WATCHDOG EVENT. THIS SYMPTOM WAS DETERMINED TO BE CAUSED BY POOR BLOCK MOVEMENT RELATED TO SYSTEM CONTROL ON PROCESSOR PCA FROM THE LOG CONTENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE REBOOTED WHILE PACING A PATIENT. THE ALLEGED FAILURE WAS OBSERVED WHILE THE DEVICE WAS IN USE ON A PATIENT, HOWEVER, NO ADVERSE PATIENT IMPACT WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE REBOOTED WHILE PACING A PATIENT. THE ALLEGED FAILURE WAS OBSERVED WHILE THE DEVICE WAS IN USE ON A PATIENT, HOWEVER, NO ADVERSE PATIENT IMPACT WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514610 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening