BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10

    MDR report key: 8385252 · Received March 4, 2019

    Report

    Report Number
    3004123209-2019-00093
    Event Type
    Death
    Date Received
    March 4, 2019
    Date of Event
    February 16, 2019
    Report Date
    May 21, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 1ST SEPTEMBER 2016. THE USER POWERED ON THE DEVICE AND WAS ISSUED WITH THE ADVISORY SPEECH PROMPTS. THE ELECTRODE PADS WERE PLACED 26 SECONDS AFTER THE DEVICE WAS SWITCHED ON. AS PER THE CLINICAL STATEMENT, THE DEVICE DID ADVISE A SHOCK ON 3 OCCASIONS BUT SUBSEQUENTLY DISARMED. THE PATIENT PRESENTED FINE VF, THE CHARACTERISTICS OF THIS FLUCTUATED AROUND THE CRITERIA SET FOR THE DETECTION OF VF. THERE WAS ARTEFACT IN THE ELECTROCARDIOGRAM (ECG) WHICH CAUSED A SHOCK TO BE ADVISED, HOWEVER, WHEN THIS ARTEFACT STOPPED, THE ALGORITHM DETERMINED THAT THE RHYTHM WAS NON-SHOCKABLE, AND A SHOCK WAS NOT ADVISED. THE DEVICE HAD BEEN PREVIOUSLY USED DURING PATIENT INVOLVED EVENTS ON A NUMBER OF OCCASIONS THROUGHOUT THE PERIOD OF INSTALLATION WITH NO APPARENT ISSUE. THE PATIENT INVOLVED EVENT SUBSEQUENT TO THIS ONE, ON THE 19TH FEBRUARY 2019, DID DELIVER TWO SHOCKS. THE INVESTIGATION TESTED THE DEVICES¿ ABILITY TO DELIVER THE SHOCK THERAPY SEQUENCE AND NO FAULT WAS FOUND. A VISUAL INSPECTION OF THE PCBA IDENTIFIED NO ABNORMALITIES. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE SAM 350P DEVICE WAS USED DURING AN ALLEGED SCA ON (B)(6) 2019. THE ELECTRODES WERE APPLIED TO THE PATIENT AND THE UNIT BEGAN ANALYSING AND ADVISED TO PRESS THE BUTTON TO SHOCK. BUT BEFORE THE SHOCK BUTTON WAS PRESSED, THE UNIT SUDDENLY COMMANDED ¿DO NOT TOUCH THE PATIENT¿ AND ANALYSED AGAIN. IT REPEATED THIS PROCESS 2 TIMES. THE PATIENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    THE SAM 350P DEVICE WAS USED DURING AN ALLEGED SCA ON (B)(6) 2019. THE ELECTRODES WERE APPLIED TO THE PATIENT AND THE UNIT BEGAN ANALYSING AND ADVISED TO PRESS THE BUTTON TO SHOCK. BUT BEFORE THE SHOCK BUTTON WAS PRESSED, THE UNIT SUDDENLY COMMANDED ¿DO NOT TOUCH THE PATIENT¿ AND ANALYSED AGAIN. IT REPEATED THIS PROCESS 2 TIMES. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178881 PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death