BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8897156 · Received August 15, 2019

    Report

    Report Number
    3004123209-2019-00270
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 29, 2019
    Report Date
    November 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 DEVICE WAS RETURNED WITH A REPORTED FAULT OF THE ON/OFF BUTTON FAILING THE SAVER EVO TEST. INFORMATION FROM THE HISTORY LOG SHOWED THE DEVICE WAS SUCCESSFULLY POWER CYCLED 48 TIMES FROM THE DATE OF INSTALLATION ON THE (B)(6) 2014 UP TO THE LAST LOG ENTRY PRIOR TO RECEIPT AT HEARTSINE ON THE (B)(6) 2019. THREE OF THOSE POWER CYCLES WERE RECORDED ON THE (B)(6) 2019, THE DAY AFTER THE DATE OF COMPLAINT. DURING INVESTIGATION 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 SUCCESSFULLY POWER CYCLED MULTIPLE TIMES VIA THE ON/OFF BUTTON WITHOUT FAULT. DETAILS FROM THE REPORTED COMPLAINT STATED THAT THE FAULT WAS DISCOVERED DURING ROUTINE TESTING OF THE DEVICE USING SAVER EVO. THE OPERATION OF THE ON/OFF BUTTON WAS VERIFIED DURING INVESTIGATION USING THE SAVER EVO DIAGNOSTIC TOOL. IT IS THEREFORE POSSIBLE THE REPORTED FAULT HAD BEEN DUE TO INCORRECT USE OF THE SAVER EVO DIAGNOSTIC TEST TOOL. 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.

    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

    AED ON/OFF BUTTON FAILED TO RESPOND DURING TEST USING SAVEREVO. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    AED ON/OFF BUTTON FAILED TO RESPOND DURING TEST USING SAVEREVO. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693499 PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1