BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10199231 · Received June 26, 2020

    Report

    Report Number
    3004123209-2020-00159
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 16, 2020
    Report Date
    November 5, 2020
    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

    THE DEVICE HISTORY RECORDS FOR THE SAM 500P DEVICE AND PAD-PAK 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) 2019 THE DEVICE WAS REPORTED TO HAVE BEEN INVOLVED IN A FLOODING AND DISPLAYING A FLASHING RED LIGHT. UPON DEVICE RECEIPT THE STATUS INDICATOR WAS OBSERVED TO BE FLASHING RED ALONGSIDE A FAILURE CHIRP AS PER REPORTED FAULT. ADDITIONALLY, THE DEVICE MEMORY LOGS COULD NOT BE DOWNLOADED AND THE DEVICE COULD NOT BE POWERED ON. MOISTURE WAS OBSERVED WITHIN THE DEVICE ACROSS THE ENTIRE PCBA, COVERING MULTIPLE CIRCUITS AND COMPONENTS, INCLUDING THE USB, RTC, AND LED DRIVE CIRCUITRIES. THIS HAD RESULTED IN MULTIPLE FAILURE MODES, INCLUDING BUT NOT LIMITED TO THE DEVICE FAILING TO POWER ON, FAILURE OF THE USB CONNECTION AND FAILURE OF THE RTC. UPON DRYING THE MOISTURE FROM THE PCBA THE DEVICE MEMORY LOGS WERE SUCCESSFULLY DOWNLOADED. INFORMATION FROM THE HISTORY LOG SHOWS THE DEVICE PERFORMED SUCCESSFUL AUTO SELF-TESTS UP TO THE (B)(6) 2020, WHICH WOULD SUGGEST THE DEVICE HAD FAILED AROUND THIS TIME. ADDITIONALLY, THE CORROSION ON THE MEMBRANE TAIL WOULD INDICATE THE DEVICE HAD BEEN IN THE PRESENCE OF MOISTURE FOR A PROLONGED PERIOD OF 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.

    Description of Event or Problem · 0

    THE AED IS FLASHING RED LIGHT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE AED IS FLASHING RED LIGHT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667907 PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1