BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,350P,PP01,EN,350-BAS-US-10

    MDR report key: 8350469 · Received February 19, 2019

    Report

    Report Number
    3004123209-2019-00072
    Event Type
    Death
    Date Received
    February 19, 2019
    Date of Event
    December 27, 2018
    Report Date
    May 21, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PERFORMED TO SPECIFICATION DURING THE REPORTED PATIENT INVOLVED EVENT. 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 (B)(6) 2014.THE DEVICE WAS REPORTED AS BEING USED DURING A PATIENT INVOLVED EVENT ON THE (B)(6) 2018 IN THE USA THE PATIENT INITIALLY PRESENTED VENTRICULAR FIBRILLATION (VF). A SHOCK WAS ADVISED AND A 150J SHOCK WAS DELIVERED. THE SHOCK WAS SUCCESSFUL IN TERMINATING THE ARRHYTHMIA. THE PATIENT¿S HEART RHYTHM WAS ASSESSED ON A FURTHER SIX OCCASIONS, BUT AS THE PATIENT NOW PRESENTED A NON-PERFUSING, NON-SHOCKABLE RHYTHM NO SHOCK WAS ADVISED. THE PATIENT HEART RHYTHM SUBSEQUENTLY CHANGED TO VF. THE USER WAS ALERTED TO ¿PRESS THE ORANGE SHOCK BUTTON¿ FOUR TIMES BUT THE BUTTON WAS NOT PRESSED, AND THE DEVICE DISARMED. THIS OCCURRED A SECOND TIME WITH THE USER AGAIN FAILING TO PRESS THE SHOCK BUTTON. THE VOLUME OF THE SPEECH PROMPTS WAS VERIFIED DURING THE INVESTIGATION AS BEING CONSISTENT WITH THE 350P PRODUCTION TEST MASTER SET AT ¿MAX¿. THERE WAS NO VISIBLE DAMAGE OR ABNORMALITIES WITH EITHER THE SPEAKER HOUSING OR THE SPEAKER ITSELF. THE SPEAKER COIL WAS MEASURED, AND NO FAULT WAS FOUND. NO MEASURABLE FAULT WAS FOUND WITH THE SHOCK BUTTON AND THE DEVICE CONTINUED TO DELIVERY SHOCK THERAPY EVEN AFTER STRESS TESTING. IF THE SAM 350P IS USED IN A NOISY ENVIRONMENT, WERE THE USER IS UNABLE TO HEAR THE VOICE PROMPTS, THE VISUAL INDICATORS WILL PROVIDE INSTRUCTION FOR USE I.E. BEGIN CPR ICON, STAND CLEAR OF PATIENT ICON, ILLUMINATED ORANGE SHOCK BUTTON WHEN SHOCK ADVISED.

    Description of Event or Problem · 0

    THIS EVENT TOOK PLACE ON THE (B)(6) 2018. A PASSENGER SUFFERED AN ALLEGED SCA. THE PASSENGER WAS SHOCKED ONE TIME. THE COMPLAINANT THOUGHT THAT THE UNIT SHOULD HAVE SHOCKED AGAIN. IT ONLY SHOCKED ONCE. THE PATIENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    THIS EVENT TOOK PLACE ON THE (B)(6) 2018. A PASSENGER SUFFERED AN ALLEGED SCA. THE PASSENGER WAS SHOCKED ONE TIME. THE COMPLAINANT THOUGHT THAT THE UNIT SHOULD HAVE SHOCKED AGAIN. IT ONLY SHOCKED ONCE. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143143 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death