BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8428875 · Received March 18, 2019

    Report

    Report Number
    3004123209-2019-00110
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 22, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Adverse Event
    Yes
    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 12TH NOVEMBER 2012. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT ¿SHOCK BUTTON FAULTY¿. INFORMATION FROM THE HISTORY LOG SHOWS THAT THE DEVICE SUCCESSFULLY RECORDS SELF-TESTS FROM THE FIRST PAD-PAK INSTALLATION DATE ON THE 22ND JANUARY 2013 UP TO THE LAST LOG ENTRY PRIOR TO RECEIPT AT HEARTSINE ON THE 10TH MARCH 2019. 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. FURTHER INFORMATION OBTAINED FROM THE DISTRIBUTOR, HTM MEDICO, STATED THE FAULTS WERE DISCOVERED DURING ROUTINE TESTING OF THE DEVICE ON SAVEREVO IN WHICH THE SHOCK BUTTON WAS TESTED (SEE ATTACHED DISTRIBUTOR EMAIL [4]). 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. THE RETURNED SAM 500P IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.

    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

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223921 PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1