BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10

    MDR report key: 8627311 · Received May 21, 2019

    Report

    Report Number
    3004123209-2019-00203
    Event Type
    Death
    Date Received
    May 21, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 360P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 360P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2017. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2017. THE DEVICE PERFORMED SUCCESSFUL WEEKLY AUTO SELF-TESTS UP TO AND INCLUDING THE (B)(6) 2019. THE DEVICE WAS REPORTED AS BEING USED DURING A PATIENT INVOLVED EVENT ON THE (B)(6) 2019 IN AUSTRALIA. AN ATTEMPT WAS MADE TO POWER ON THE DEVICE AT 23:25:31H. HOWEVER, THE DEVICE NEVER PROGRESSED TO ISSUING THE SPEECH PROMPTS PRIOR TO POWERING OFF. THE TECHNICAL LOG DOES NOT REGISTER THE ON/OFF BUTTON BEING PRESSED TO POWER OFF THE DEVICE AND THE DEVICE NEVER ENTERED THE SHUTDOWN SEQUENCE. THIS MAY INDICATE THE PAD-PAK HAD NOT BEEN CORRECTLY INSTALLED. IMMEDIATELY AFTER THIS A FURTHER ATTEMPT WAS MADE TO SWITCH ON THE DEVICE AT 23:25:35H. THE DEVICE DID POWER ON AND THE ELECTRODE PADS WERE DETECTED AS BEING ATTACHED TO THE PATIENT. THE USER WAS ISSUED WITH THE ¿ADULT PATIENT¿ VOICE PROMPT BUT THE DEVICE THEN POWERED DOWN. THE ON/OFF BUTTON WAS NOT DETECTED AS BEING PRESSED TO POWER OFF THE DEVICE AND THE SHUTDOWN SEQUENCE WAS NOT RECORDED WITHIN THE DEVICE MEMORY LOG. WHEN THE DEVICE POWERS OFF IN THIS MANNER IT CAN RESULT IN AN ERRONEOUS LOW BATTERY WARNING APPEARING IN SAVER EVO, DUE TO THE DEVICE NOT SHUTTING DOWN CORRECTLY. THE DEVICE WAS UNABLE TO BE SUCCESSFULLY POWERED ON AND ANALYSE THE PATIENT¿S HEART RHYTHM DURING THE REPORTED EVENT. THE ELECTRODE PADS DO APPEAR TO HAVE BEEN PLACED ON THE PATIENT AS AN IMPEDANCE MEASUREMENT WAS BRIEFLY DETECTED. POWER WAS REMOVED FROM THE DEVICE RESULTING IN IT UNABLE TO ENTER THE SHUTDOWN SEQUENCE. THIS RESULTED IN AN ERRONEOUS LOW BATTERY BEING LOGGED WITHIN THE USER ACCESSIBLE MEMORY LOG. THERE WAS NO AUDIO PROMPT GIVEN FOR A LOW BATTERY. THE LOW BATTERY, DISPLAYED ON SAVER EVO, WOULD HAVE BEEN IDENTIFIED DURING THE POST EVENT REVIEW. GIVEN NO FAULT WAS FOUND WITH THE DEVICE, OR THE RETURNED PAD-PAK, THE REPORT CAN ONLY ASSUME THE PAD-PAK WAS INCORRECTLY SEATED WITHIN THE UNIT. AN INCORRECTLY SEATED PAD-PAK COULD POTENTIALLY HAVE BEEN DISTURBED WHEN THE ELECTRODES WERE BEING REMOVED, THUS RESULTING IN THE DEVICE POWERING OFF. NO FAULT FOUND WITH THE RETURNED SAM 360P.

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT. A LOW BATTERY PROMPT WAS ISSUED SIX TIMES DURING AN EVENT AT A TRAIN STATION IN (B)(6). THE DEVICE DISPLAYS A GREEN STATUS INDICATOR. PATIENT IS BELIEVED TO HAVE DIED.

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT. A LOW BATTERY PROMPT WAS ISSUED SIX TIMES DURING AN EVENT AT A TRAIN STATION IN AUSTRALIA. THE DEVICE DISPLAYS A GREEN STATUS INDICATOR. PATIENT IS BELIEVED TO HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420390 PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR