BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7608809 · Received June 18, 2018

    Report

    Report Number
    3004123209-2018-00406
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    May 28, 2018
    Report Date
    July 17, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC ( IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT : DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2011. THE DEVICE WAS RETURNED WITH A REPORTED FAULT OF ¿SHOCK KEY STUCK¿ ERRORS FOUND IN THE DEVICE MEMORY, WHICH WAS CONFIRMED UPON RECEIPT AT HEARTSINE. NO FAULT WAS MEASURED ON THE SHOCK KEY LINE. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. ADDITIONAL STRESS TESTING WAS CARRIED OUT AT 50°C 95%RH FOR 3 DAYS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS COMBINED TESTING EQUATES TO APPROXIMATELY 6.5 YEARS OF NORMAL USE WITHOUT FAULT. THE OPERATION OF THE SHOCK BUTTON WAS VERIFIED AT DIFFERENT STAGES DURING THIS PERIOD. THE REPORTED FAULT COULD ONLY BE REPLICATED BY HOLDING THE SHOCK BUTTON DURING POWER ON. GIVEN THAT NO MEASURABLE FAULT WAS FOUND ON THE DEVICE, IT IS ASSUMED THE REPORTED FAULT WAS CAUSED BY AN EXTERNAL FORCE BEING APPLIED TO THE SHOCK BUTTON DURING POWER ON. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPT ALONGSIDE A FLASHING RED STATUS INDICATOR. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH A SAM 350P.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. ERROR SHOCK BUTTON STUCK SHOWN IN MEMORY.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. ERROR SHOCK BUTTON STUCK SHOWN IN MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454618 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1