BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 6011586 · Received October 7, 2016

    Report

    Report Number
    1218950-2016-06353
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUSPECTED THE HEARTSTART MRX HAD MALFUNCTIONED AND REQUESTED IT TO BE TESTED. THE ECG LEAD WIRE WAS NOT A PHILIPS PRODUCT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND CONFIRMED THE ROOT CAUSE OF THIS EVENT WAS USING THE NON-PHILIPS ECG LEAD WIRE. THE CUSTOMER WAS ADVISED TO USE PHILIPS ACCESSORIES. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. THE CUSTOMER IS INSTRUCTED IN THE HEARTSTART XL INSTRUCTIONS FOR USE (PUBLICATION (B)(4), EDITION 7) TO USE ONLY PHILIPS ACCESSORIES: "USE OF SUPPLIES OR ACCESSORIES OTHER THAN THOSE RECOMMENDED BY PHILIPS MAY COMPROMISE PRODUCT PERFORMANCE" (PAGE II) AND "WARNING: USE ONLY THE MULTIFUNCTION DEFIB ELECTRODE PADS, BATTERY, AND ACCESSORIES LISTED" (PAGE 13-28). THE ROOT CAUSE OF THE EVENT WAS THE USE OF THE NON-PHILIPS ECG LEAD WIRE.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL DEFIBRILLATOR "HAS THE HEARTBEAT WHEN THE PATIENT DIED." THE PATIENT HAD BEEN SENT TO THE EMERGENCY DEPARTMENT BECAUSE OF A CAR ACCIDENT. THE CUSTOMER USED A MINDRAY MONITOR FOR PATIENT VITAL SIGNS AND FOUND THAT THE PATIENT HAD NO HEART RATE AND THE HEART WAVE PULLED STRAIGHT. AT THE SAME TIME, THEY ALSO USED THE HEARTSTART XL DEFIBRILLATOR MONITOR BUT THE XL DISPLAYED SOME CLUTTER WAVE AND HEART RATE. THIS EVENT OCCURRED AFTER THE ECG LEAD WIRE WAS CHANGED. THE USER DOES NOT BELIEVE THAT THE DEVICE BEHAVIOR IMPACTED THE PATIENT OUTCOME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL DEFIBRILLATOR "HAS THE HEARTBEAT WHEN THE PATIENT DIED." ADDITIONAL DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662785 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death