BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,USB,EN,500-BAS-CN-10

    MDR report key: 7690113 · Received July 16, 2018

    Report

    Report Number
    3004123209-2018-00450
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 23, 2018
    Report Date
    October 10, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 500P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 22ND MAY 2017. A HIGH VOLTAGE BREAKDOWN OCCURRED DURING THE REPORTED SCA ON THE (B)(6) 2018. THIS RESULTED IN THE MEASURABLE DAMAGE TO Q11 AND Q14. WHEN Q11/Q14 WAS REPLACED THE REPORTED FAULT COULD NOT BE REPEATED. THIS WOULD INDICATE A FAILURE OCCURRED ON THE SWITCHES THAT CONTROL THE PHASE 2 DISCHARGE. A LATENT FAILURE OF EITHER COMPONENT WOULD HAVE RESULTED IN THE CORRESPONDING IGBT TO HAVE BECOME DAMAGED. THE ABILITY OF THE DEVICE TO PROVIDE THE SHOCK THERAPY SEQUENCE WAS TESTED DURING OUT QAT ON THE (B)(6) 2017. THIS WOULD INDICATE A LATENT FAILURE OF THE COMPONENT HAD OCCURRED SOMETIME AFTER THIS DATE. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 0

    THIS IS A PATIENT INVOLVED EVENT, A DEVICE SERVICE REQUEST PROMPT WAS ISSUED DURING SCA EVENT. THE PATIENT SURVIVED TO HOSPITAL ADMISSION.

    Description of Event or Problem · 0

    THIS IS A PATIENT INVOLVED EVENT, A DEVICE SERVICE REQUEST PROMPT WAS ISSUED DURING SCA EVENT. THE PATIENT SURVIVED TO HOPITAL ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532985 PACKAGE,500P,PP03,USB,EN,500-BAS-CN-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR