BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7731026 · Received July 30, 2018

    Report

    Report Number
    3004123209-2018-00505
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 25, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURI NG AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIE S ON THE (B)(6)2015 . THE COMPLAINT WAS RAISED FOLLOWING A POST MARKET REVIEW ON A PATIENT INVOLVED EVENT WHICH TOOK PLACE ON THE (B)(6)2018 . THAT REVIEW INDICATED THAT AN INAPPROPRIA TE SHOCK HAD OCCURRED. A SHOCK WAS DELIVERED 2 MINUTES AND 20 SECONDS INTO THE EVENT. A CLINICAL AND ALGORITHM REVIEW IDENTIFIED THIS AS AN INAPPROPRIA TE SHOCK. THE ISSUE WAS DUE TO THE SENSITIVITY AND SPECIFICITY OF THE ALGORITHM. AS IT IS LESS THAN 100%, A MINIMAL PROPORTION OF DIAGNOSTIC DECISIONS WILL NOT BE CLINICALLY OPTIMAL AND THEREFORE IN THIS INSTANCE AN INCORRECT SHOCK WAS DELIVERED. THE ALGORITHM IS CONTINUALLY REVIEWED AND REFINED USING FIELD DATA TO VALIDATE ANY ALGORITHM IMPROVEME NTS. THE SAM 350P ECG ARRHYTHMIA ANALYSIS ALGORITHM PERFORMANC E HAS BEEN EXTENSIVELY EVALUATED BY USING SEVERAL DATABASES OF REAL-LIFE ECG TRACES. INCLUDED IN THIS ARE THE AMERICAN HEART ASSOCIATION¿ S (AHA) DATABASE AND THE MASSACHUSE TTS INSTITUTE OF TECHNOLOGY MIT ¿ NST DATABASE. THE SAM 350P ECG ARRHYTHMIA ANALYSIS ALGORITHM¿S SENSITIVITY AND SPECIFICITY MEET THE REQUIREMEN TS OF IEC60601-2- 4. THE DEVICE WAS INSPECTED AND TESTED AT HEARTSINE ON THE 12TH JUNE 2019. NO FAULT WAS FOUND WITH THE FUNCTIONALITY OF THE DEVICE. CORRECTION TO G4 AWARENESS DATE CHANGED FROM (B)(6)2018 TO (B)(6)2018 AND D10 DATE OF RETURN MISSING FROM FIRST SUPPLEMENT AL IS (B)(6)2019.

    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. NO REWORK WAS CONDUCTED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 9TH JUNE 2015. THE COMPLAINT WAS RAISED FOLLOWING A POST MARKET REVIEW ON A PATIENT INVOLVED EVENT WHICH TOOK PLACE ON (B)(6) 2018. IN THIS INSTANCE THE ALGORITHM DIAGNOSED SHOCKABLE RHYTHM WHEN IT IS NON-SHOCKABLE. DUE THE PUBLISHED SENSITIVITY AND SPECIFICITY OF THE ALGORITHM A MINIMAL PROPORTION OF DIAGNOSTIC DECISIONS WILL NOT BE CLINICALLY OPTIMAL AND THEREFORE IN THIS INSTANCE A SHOCK WAS DELIVERED WHEN IT WAS NOT CLINICALLY NECESSARY. THE PATIENT SURVIVED TO HOSPITAL ADMISSION. THE ALGORITHM IS CONTINUALLY REVIEWED AND REFINED USING FIELD DATA TO VALIDATE ANY ALGORITHM IMPROVEMENTS. THE SAM 350P ECG ARRHYTHMIA ANALYSIS ALGORITHM PERFORMANCE HAS BEEN EXTENSIVELY EVALUATED BY USING SEVERAL DATABASES OF REAL-LIFE ECG TRACES. INCLUDED IN THIS ARE THE AMERICAN HEART ASSOCIATION¿S (AHA) DATABASE AND THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY MIT ¿ NST DATABASE. THE SAM 350P ECG ARRHYTHMIA ANALYSIS ALGORITHM¿S SENSITIVITY AND SPECIFICITY MEET THE REQUIREMENTS OF IEC60601-2-4.

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT . POSSIBLE INAPPROPRIATE THERAPY/SHOCK DURING SCA EVENT WAS ALLEGED. THIS INFORMATION WAS PROVIDED BY HEARTSINE CLINICAL TEAM DURING CLINICAL REVIEW. PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT . POSSIBLE INAPPROPRIATE THERAPY/SHOCK DURING SCA EVENT WAS ALLEGED. THIS INFORMATION WAS PROVIDED BY HEARTSINE CLINICAL TEAM DURING CLINICAL REVIEW. PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 0

    THIS WAS A PATIENT INVOLVED EVENT . POSSIBLE INAPPROPRIATE THERAPY/SHOCK DURING SCA EVENT WAS ALLEGED. THIS INFORMATION WAS PROVIDED BY HEARTSINE CLINICAL TEAM DURING CLINICAL REVIEW. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573967 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR