BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD-PAK

    MDR report key: 8486149 · Received April 5, 2019

    Report

    Report Number
    3004123209-2019-00149
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    April 3, 2019
    Report Date
    July 11, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    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 AND PAD-PAK WERE 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 18TH DECEMBER 2014. UPON RECEIPT, THE DEVICE WAS ATTEMPTING TO BOOT UP FROM THE USB 5V SUPPLY WHEN CONNECTED TO PC. AS THIS IS SIGNIFICANTLY LOWER THAN THE 18V REQUIRED TO POWER ON THE UNIT, THE DEVICE WAS FAILING SELF-TESTS DUE TO LOW BATTERY, TRIGGERING A MICROPROCESSOR RESET DURING EACH BOOT UP ATTEMPT. THE DEVICE THEREFORE DID NOT COMPLETE THESE POWER CYCLES, RESULTING IN THE REPORTED ¿WARNING¿ PROMPTS. THE FAULTS COULD NOT BE REPLICATED WITH A NEW MICROPROCESSOR INSTALLED. THIS WOULD CONFIRM A FAILURE OF THE ORIGINAL MICROPROCESSOR AND HAD LIKELY BEEN DUE TO AN INTERNAL SHORT WITHIN THE COMPONENT. THE DEVICE WAS SUBJECT TO SAM 500P FINAL SYSTEM TEST SPECIFICATION (H017-014-204) ON THE 18TH DECEMBER 2014 ¿ DURING THIS TESTING, THE FUNCTIONALITY OF THE USB CIRCUITRY WAS VERIFIED, AND NO FAULT WAS FOUND ON THE UNIT. THIS WOULD THEREFORE INDICATE THE MICROPROCESSOR HAD FAILED AFTER THIS DATE. IT IS UNCLEAR WHEN THE COMPONENT HAD FAILED, AS THE DEVICE ONLY PRESENTED THE FAULT IN THE PRESENCE OF A USB CONNECTION. HOWEVER, INFORMATION FROM THE HISTORY LOG SHOWED MULTIPLE SELF-TEST FAILS DUE TO LOW BATTERY FROM THE (B)(6) 2019. IT IS THEREFORE LIKELY THE FAULT HAD INITIALLY BEEN DETECTED ON THIS DATE. 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 NEW SAM 500P.

    Description of Event or Problem · 0

    WHEN USB DATA CABLE PLUGGED INTO DEVICE WARNING PROMPT WAS HEARD. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    WHEN USB DATA CABLE PLUGGED INTO DEVICE WARNING PROMPT WAS HEARD. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281744 HEARTSINE SAMARITAN 500P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1