BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 8124130 · Received December 3, 2018

    Report

    Report Number
    3004123209-2018-00722
    Event Type
    Death
    Date Received
    December 3, 2018
    Date of Event
    October 11, 2018
    Report Date
    June 11, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE AND PAD-PAK (LOT B1101) WERE 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 18TH APRIL 2014. DURING THE REPORTED PATIENT-INVOLVED EVENT (B)(6) 2018, THE DEVICE WAS POWERED ON AND THE USER WAS ISSUED WITH THE NORMAL ADVISORY SPEECH PROMPTS. THE HEART RHYTHM WAS ASSESSED ON SIX OCCASIONS DURING THE EVENT WITH NO SHOCK ADVISED ON EACH OCCASION. THE PATIENT PRESENTED ASYSTOLE, WHICH IS A NON-SHOCKABLE RHYTHM. THE DEVICE THEREFORE PERFORMED TO SPECIFICATION THROUGHOUT THIS EVENT. DURING INVESTIGATION, THE DEVICE DELIVERED THE SHOCK THERAPY SEQUENCE WITHOUT FAULT. THE DEVICE WAS CONFIRMED TO RECORD ECG DATA ACCURATELY WITHOUT NOISE OR OTHER ABNORMALITIES. THE IMPEDANCE DETECTION CIRCUITRY WAS ALSO TESTED UNDER STRESS, WITH NO FAULT FOUND. FURTHERMORE, NO FAULT WAS FOUND ON THE RETURNED PAD-PAK (LOT B1101), INCLUDING ITS ELECTRODES, CABLES AND CRIMP CONNECTIONS. THE DEVICE HAD BEEN PREVIOUSLY USED DURING A PATIENT INVOLVED EVENT ON THE (B)(6) 2014 WITH NO APPARENT ISSUE. DURING THIS EVENT THE DEVICE SUCCESSFULLY DELIVERED THREE SHOCKS. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    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

    THIS EVENT OCCURED IN THE USA. A 350P WAS USED IN AN ALLEGED SCA. CPR WAS PERFORMED ON THE PATIENT BEFORE THE DEVICE WAS USED. IT WAS ALLEGED THAT THE DEVICE KEPT SAYING "UNABLE TO SHOCK¿. PARAMEDICS ARRIVED ON THE SCENE AND TOOK OVER. PATIENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    THIS EVENT OCCURED IN THE USA. A 350P WAS USED IN AN ALLEGED SCA. CPR WAS PERFORMED ON THE PATIENT BEFORE THE DEVICE WAS USED. IT WAS ALLEGED THAT THE DEVICE KEPT SAYING "UNABLE TO SHOCK¿. PARAMEDICS ARRIVED ON THE SCENE AND TOOK OVER. PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965584 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death