BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8590305 · Received May 8, 2019

    Report

    Report Number
    3004123209-2019-00164
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 1, 2019
    Report Date
    July 22, 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

    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)2013 . THE REPORTED FAULT COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT ¿ON OFF BUTTON FAIL DURING SAVER EVO TESTING¿ INFORMATION FROM THE HISTORY LOG SHOWS THAT THE DEVICE SUCCESSFULLY RECORDS SELF-TESTS FROM THE FIRST PAD-PAK INSTALLATION DATE ON THE (B)(6)2013 UP TO THE LAST LOG ENTRY PRIOR TO RECEIPT AT HEARTSINE ON THE(B)(6)2019. DURING THIS TIME THE DEVICE WAS MANUALLY POWER CYCLED ON FIVE OCCASIONS ALL OF UNDER 1 MINUTE DURATION. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. DURING THIS TIME THE DEVICE WAS MANUALLY POWER CYCLED ON MULTIPLE OCCASIONS VIA THE ON/OFF BUTTON PASSING A MANUAL SELF-TEST ON EACH OCCASION. THIS IS EQUIVALENT TO APPROXIMATELY (B)(4) MONTHS OF NORMAL USE WITHOUT FAULT. DETAILS FROM THE REPORTED COMPLAINT STATED THAT THE FAULT WAS DISCOVERED DURING ROUTINE TESTING OF THE DEVICE ON SAVEREVO IN WHICH THE ON/OFF BUTTON WAS TESTED. THE ON/OFF BUTTON WAS VERIFIED DURING THE INVESTIGATION AND USING THE SAVEREVO DIAGNOSTIC TOOL DURING TESTING. THEREFORE, IT IS POSSIBLE THAT INCORRECT USE OF SAVEREVO DIAGNOSTIC TEST TOOL MAY HAVE CAUSED THE REPORTED ISSUE. 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.

    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

    ON OFF BUTTON FAIL DURING SAVER EVO TESTING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    ON OFF BUTTON FAIL DURING SAVER EVO TESTING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386454 PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1