BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7612812 · Received June 19, 2018

    Report

    Report Number
    3004123209-2018-00414
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    June 4, 2018
    Report Date
    August 29, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC (IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT: DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 9TH JUNE 2011. THE RETURNED PAD-PAK DHR WAS INVESTIGATED SHOWING IT WAS 1 OF 200 PAD-PAK¿S MANUFACTURED UNDER LOT B1121. ALL PAD-PAK¿S WERE SUBJECTED TO A BATTERY VOLTAGE TEST ON THE 13TH NOVEMBER 2014 WITH NO RECORDED FAILS. 197 OF THOSE PAD-PAKS WERE SHIPPED TO HEARTSINE INC. BLOWN FUSE WITHIN RETURNED PAD-PAK. THE DEVICE WAS RETURNED TO HEARTSINE WITH A REPORTED FAULT OF SWITCHING ON AUTOMATICALLY. DEVICES RETURNED FOR SWITCHING ON AUTOMATICALLY NORMALLY HAVE SYMPTOMS INCLUDING AN EXCESS CURRENT DRAIN AND MULTIPLE MANUAL POWER ONS MAINLY OF TEN-MINUTE DURATION IN THE HISTORY LOG THAT MAY BE ATTRIBUTED TO A FAILING MEMBRANE. THE CURRENT DRAIN OF THE DEVICE WAS WITHIN SPECIFICATION. THE DEVICE RECORDED 20 MANUAL POWER ONS OF MAINLY UNDER ONE MINUTE DURATION FROM THE DATE OF INSTALLATION, INCLUDING ONE RECORDED ON THE DATE OF COMPLAINT, THE (B)(6) 2018. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. ADDITIONAL STRESS TESTING WAS CARRIED OUT AT 50°C 95%RH FOR 5 DAYS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES THIS COMBINED TESTING EQUATES TO APPROXIMATELY 9.5 YEARS OF NORMAL USE WITHOUT FAULT. THE DEVICE FAILED TO POWER ON WITH THE RETURNED PAD-PAK INSTALLED AND NO STATUS LED WAS VISIBLE. UPON FURTHER INVESTIGATION THE RETURNED PAD-PAK FUSE WAS MEASURED AND FOUND TO HAVE BLOWN, RESULTING IN A VOLTAGE OF 0V BEING MEASURED ACROSS THE BATTERY TERMINALS. AS NO FAULT WAS FOUND WITH THE SAM PAD DEVICE DURING TESTING, THIS WOULD SUGGEST THE BLOWN FUSE IN THE RETURNED PAD-PAK MAY HAVE BEEN DUE TO A HANDLING ISSUE RESULTING IN A SHORT CIRCUIT BETWEEN THE TERMINALS, OR THE PAD-PAK HAD BEEN USED IN ANOTHER DEVICE. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES THAT HAVE BEEN RETURNED FROM THE FIELD AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH A SAM 350P.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. ENDUSER ALLEGES THAT SAM300P UNIT POWERS ON BY ITSELF; NON FSCA UNIT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. ENDUSER ALLEGES THAT SAM300P UNIT POWERS ON BY ITSELF; NON FSCA UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458947 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1