BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10

    MDR report key: 8543120 · Received April 24, 2019

    Report

    Report Number
    3004123209-2019-00156
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 1, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 (B)(6) 2018. UPON RECEIPT THE DEVICE WAS FAILING SELF-TESTS DUE TO A SPEECH CHIP LABEL MISMATCH ERROR. A FRACTURED SOLDER JOINT ON THE KEY3_BUTTON LINE OF THE J12 CONNECTOR HAD RESULTED IN THE TRACK REMAINING OPEN CIRCUIT, LEADING TO THE FAILED SELF-TESTS. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPT ALONGSIDE A FLASHING RED STATUS LED AND FAILURE CHIRP, AS PER THE REPORTED FAULT. THE FAULT COULD NOT BE REPLICATED AFTER THE SOLDER JOINT WAS REFLOWED. THIS CONFIRMED THE FAILURE HAD BEEN DUE TO THE FRACTURED SOLDER JOINT. INFORMATION FROM HEARTSINE RECORDS AND THE DEVICE MEMORY INDICATE THE DEVICE HAD PERFORMED TO SPECIFICATION DURING OUT QAT ON THE (B)(6) 2018 BUT FAILED ON INSTALLATION ON THE (B)(6) 2018. THIS WOULD INDICATE THE SOLDER JOINT HAD BECOME FRACTURED BETWEEN THESE DATES. 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

    RED STATUS INDICATOR FLASHING AND BEEPING BEFORE PAD-PAK EXPIRY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    RED STATUS INDICATOR FLASHING AND BEEPING BEFORE PAD-PAK EXPIRY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340180 PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1