BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7750965 · Received August 6, 2018

    Report

    Report Number
    3004123209-2018-00509
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 1, 2018
    Report Date
    September 4, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE REVIEW REVEALED NO REWORK WAS CONDUCTED AND NO CONCESSIONS/DEVIATIONS RELATED TO THE ISSUE WERE IDENTIFIED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2011. ON RECEIPT, THE DEVICE WAS SHUTTING DOWN WITH A ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPT. THIS WOULD CONFIRM THE REPORTED FAULT. INFORMATION FROM THE TECHNICAL LOG AND THE DEVICE HISTORY RECORD INDICATED THAT THE LANGUAGE HAD BEEN CHANGED AFTER DISPATCH FROM HEARTSINE. THE DEVICE LANGUAGE WAS SUCCESSFULLY REPROGRAMMED; NO WARNINGS WERE THEN GIVEN AT SHUTDOWN, THIS WOULD INDICATE A FAULT HAD DEVELOPED WITH THE DIGITAL SPEECH CHIP, LIKELY DURING AN ATTEMPTED LANGUAGE CHANGE. AS THE LANGUAGE AND PROMPTS ARE CHECKED DURING TESTING AT HEARTSINE AS PER H017-014-204, THE INVESTIGATION CONCLUDES THIS ISSUE HAD OCCURRED AFTER SHIPPING FROM HEARTSINE. AFTER THE SUCCESSFUL REPROGRAMMING OF THE DIGITAL SPEECH CHIP, THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES, IN ORDER TO VERIFY THE OPERATION OF THE COMPONENT AND RULE OUT ANY POTENTIAL DRY SOLDER JOINTS. NO FAULT WAS OBSERVED. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. THE FAULT WAS REPLICATED DURING THE INVESTIGATION BY REMOVING THE USB CABLE DURING THE LANGUAGE REPROGRAMMING. THIS WOULD CONFIRM A FAILED LANGUAGE CHANGE HAD RESULTED IN THE REPORTED FAULT. THE ERROR DURING THE LANGUAGE CHANGE COULD HAVE BEEN CAUSED BY A PROBLEM WITH THE USER HARDWARE, OR, THE USB MAY HAVE BEEN DISCONNECTED PREMATURELY DURING THE PROCESS. 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 ANOTHER DEVICE OF THE SAME MODEL.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE SERVICE PROMPT HEARD.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE SERVICE PROMPT HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595438 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1