BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10

    MDR report key: 8897143 · Received August 15, 2019

    Report

    Report Number
    3004123209-2019-00268
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 22, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 360P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 360P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6)2018. UPON RECEIPT THE DEVICE WAS FAILING SELF-TESTS DUE TO A SHOCK KEY ERROR. A FRACTURED SOLDER JOINT ON THE SHOCK_BUTTON LINE OF THE J12 CONNECTOR HAD RESULTED IN THE TRACK REMAINING OPEN CIRCUIT, LEADING TO FAILED SELF-TESTS DUE TO A SHOCK KEY ERROR. THE USER WOULD HAVE BEEN ALERTED WITH ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPTS AS PER THE REPORTED FAULT, ALONGSIDE A FLASHING RED STATUS LED. THE FAULT COULD NOT BE REPLICATED AFTER THE SOLDER JOINT WAS REFLOWED. THIS CONFIRMED A FAILURE OF THE MEMBRANE DUE TO THE FRACTURED SOLDER JOINT. INFORMATION FROM THE HISTORY LOG SHOWED THE DEVICE WAS INSTALLED ON THE (B)(6)2019 AND PERFORMED TO SPECIFICATION FOR OVER 2 MONTHS PRIOR ISSUING THE FIRST SHOCK KEY ERROR ON THE (B)(6)2019 . THIS WOULD INDICATE THE SOLDER JOINT HAD BECOME FRACTURED AROUND THIS TIME. 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 360P.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. ERROR MESSAGE SAYING ¿DEVICE SERVICE REQUIRED¿.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. ERROR MESSAGE SAYING ¿DEVICE SERVICE REQUIRED¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691356 PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1