BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 6081462 · Received November 7, 2016

    Report

    Report Number
    3004123209-2016-01620
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 25, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE USER FIRST INSTALLED THE PAD-PAK ON THE (B)(6) 2015 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2016. THE DEVICE RECORDS MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION BETWEEN THE (B)(6) 2016. THE PAD-PAK BECAME DEPLETED DURING THIS TIME. THE RETURNED PAD-PAK WAS INSTALLED AND THE DEVICE FAILED TO POWER ON, NO STATUS LED WAS VISIBLE. THIS WOULD CONFIRM THE REPORTED FAULT. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE PASSED A SELF-TEST. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. THE DEVICE POWERED ON AFTER SHUTDOWN. THIS INDICATES A FAULT. A TEST SHOCK WAS DELIVERED WITHOUT FAULT AND AN ACCEPTABLE MEASUREMENT WAS RECORDED. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO COMPONENT FAILURE. THIS RESULTED IN AN EXCESS CURRENT DRAIN AND WOULD ACCOUNT FOR THE MANUAL POWER UPS WHICH DEPLETED THE RETURNED PAD-PAK. AS THE PAD-PAK BECAME FURTHER DEPLETED NO LED OR FAILURE CHIRP WOULD HAVE BEEN PRESENT. THIS WOULD CONFIRM THE REPORTED FAULT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO STATUS INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734048 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1