BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 9383097 · Received November 27, 2019

    Report

    Report Number
    1218950-2019-09021
    Event Type
    Death
    Date Received
    November 27, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 7, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. A PHILIPS FIELD SERVICE ENGINEER DID NOT EVALUATE THE DEVICE AS THE DEVICE IS END OF LIFE (END OF SUPPORT).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL MONITOR / DEFIBRILLATOR FAILED TO SHOCK A PATIENT DURING TREATMENT OF VENTRICULAR FIBRILLATION. THE DEFIBRILLATOR WAS INITIALLY TURNED TO AED MODE USING NON-PHILIPS PADS, THEN TURNED TO OFF POSITION, BEFORE TURNING UP TO 150 JOULES. THE DEVICE WAS CHARGED AND, AFTER IT WAS CHARGED, IT DID NOT GIVE THE SHOCK OPTION BUT A DISARM OPTION CAME UP INSTEAD. THE DEVICE WAS THEN SHUT OFF AGAIN AND TURNED BACK ON TO CHARGE AND THE SAME MESSAGE APPEARED. THE DEVICE WAS TAKEN OUT OF SERVICE AND ANOTHER DEVICE AVAILABLE ON THE UNIT WAS USED TO DEFIBRILLATE. THE PATIENT DIED. THE CUSTOMER BIOMED ADVISED THAT THE DEFIBRILLATOR WAS TESTED AFTER THE INCIDENT AND IT PASSED ALL TESTING. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. THE CUSTOMER WAS USING NON-PHILIPS PADS DURING THE EVENT. THE HEARTSTART XL INSTRUCTIONS FOR USE (PUBLICATION M4735-91900, PAGE II) LISTS A WARNING STATING: ¿USE OF SUPPLIES OR ACCESSORIES OTHER THAN THOSE RECOMMENDED BY PHILIPS MAY COMPROMISE PRODUCT PERFORMANCE.¿ A PHILIPS FIELD SERVICE ENGINEER DID NOT EVALUATE THE DEVICE AS THE DEVICE IS END OF LIFE (END OF SUPPORT). ACCORDING TO SERVICE BULLETIN SB86100166D, THE M4735A HEART/START XL PORTABLE DEFIBRILLATOR/MONITOR WAS DISCONTINUED ON 31-DECEMBER -2013. ALL OPTIONS ASSOCIATED WITH THIS DEFIBRILLATOR WERE DISCONTINUED AS OF 31-DECEMBER-2013. THE END OF SUPPORT DATE FOR THE DEVICE IS 31-DECEMBER -2018. THE CUSTOMER WAS AWARE OF THE END OF LIFE TERMS AND THE DEVICE REMAINS AT THE CUSTOMER SITE. AFTER EVALUATING ALL OF THE INFORMATION GATHERED ASSOCIATED WITH THIS PARTICULAR EVENT, PHILIPS WAS UNABLE TO DETERMINE THE ALLEGED DEVICE BEHAVIOR BY THE CUSTOMER. IT IS NOT TYPICAL DEVICE BEHAVIOR TO PRESENT ¿DISARM¿ MESSAGE IN THE MODE MENTIONED BY THE CUSTOMER. PHILIPS ALSO TRIED TO GATHER CASE EVENT FILES, WHICH WERE NOT AVAILABLE AT THIS TIME. AT THIS TIME PHILIPS IS NOT ABLE TO CONFIRM IF THERE IS A RELATION BETWEEN THE ALLEGED MALFUNCTION AND THE OUTCOME OF THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL MONITOR / DEFIBRILLATOR FAILED TO SHOCK A PATIENT AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. THE OUTCOME OF DEATH OCCURRED WHILE THE DEVICE WAS IN USE ON A PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180242 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death