BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP07,EN,500-BAS-BA-10

    MDR report key: 8193144 · Received December 23, 2018

    Report

    Report Number
    3004123209-2018-00749
    Event Type
    Malfunction
    Date Received
    December 23, 2018
    Date of Event
    December 2, 2018
    Report Date
    February 12, 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 3RD FEBRUARY 2015. THE REPORTED FAULT COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT ¿AED SHOCK BUTTON FAULTY¿. INFORMATION FROM THE HISTORY LOG SHOWS THAT THE DEVICE PERFORMED ALL WEEKLY AUTO SELF-TESTS FROM INSTALLATION ON THE (B)(6) 2015 UP TO THE LAST LOG ENTRY ON THE (B)(6) 2018. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. THE SHOCK 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

    AED SHOCK KEY BUTTON FAULTY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    AED SHOCK KEY BUTTON FAULTY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032450 PACKAGE,500P,PP07,EN,500-BAS-BA-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1