BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD-PAK

    MDR report key: 7788063 · Received August 16, 2018

    Report

    Report Number
    3004123209-2018-00546
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    August 1, 2018
    Report Date
    October 4, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    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 AND PAD-PAK 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 28TH MARCH 2018. DURING THE INVESTIGATION, IT WAS OBSERVED THAT CRYSTAL Y4 WAS DAMAGED. THE DEVICE WAS PLACED IN THE HUMIDITY CHAMBER FOR 5 DAYS. THE STRESS TEST RESULTED IN AN UNSTABLE OUTPUT FROM CRYSTAL Y4. THIS FAILURE RESULTED IN THE DEVICE UNABLE TO ISSUE ANY AUDIBLE PROMPTS. CRYSTAL Y4 AND THE ASSOCIATED CIRCUITRY PROVIDE PLAYBACK OF PRE-STORED MESSAGES THAT ARE SAMPLED AT 12.8MHZ WHICH PROVIDE THE USER WITH AUDIBLE ASSISTANCE. DUE TO THE DEVICE NOT ISSUING ANY AUDIBLE PROMPTS IT WAS MOST LIKELY THAT THE USER ASSUMED THAT THE DEVICE WAS FAILING TO POWER ON. THE FAULT COULD NOT BE REPLICATED WHEN CRYSTAL Y4 WAS REPLACED. DUE TO THE NATURE OF THE DAMAGE CAUSED TO THE CRYSTAL Y4, IT IS ASSUMED THAT THE DAMAGE SUSTAINED TO THE COMPONENT OCCURRED DURING THE MANUFACTURING PROCESS OF THE DEVICE. THE DAMAGED COMPONENT WOULD ACCOUNT FOR THE DEVICE PERFORMING INTERMITTENTLY BOTH IN THE TECHNICAL LOG AND OBSERVED DURING THE INVESTIGATION. FURTHERMORE, WHEN THE CRYSTAL Y4 WAS REPLACED, THE DEVICE WAS AGAIN LEFT IN THE HUMIDITY CHAMBER AT 50°C 95%RH WHILE PERFORMING SELF-TESTS EVERY 20 MINUTES FOR 5 DAYS. THE UNIT WAS POWER CYCLED AT VARIOUS STAGES DURING THIS TESTING WITH ALL SPEECH PROMPTS GIVEN AS NORMAL AND THE DEVICE RECORDED ALL AUTO SELF-TESTS. 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

    DEVICE WILL NOT SWITCH ON. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632868 HEARTSINE SAMARITAN 350P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1