BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 5976296 · Received September 26, 2016

    Report

    Report Number
    3004123209-2016-01336
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 28, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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 HISTORY LOG FOR THE DEVICE SHOWED THE DEVICE WAS FIRST INSTALLED ON (B)(6) 2014 AND THAT IT PERFORMED TO SPECIFICATION UP TO AND INCLUDING THE LAST LOG ENTRY ON (B)(6) 2016. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE PASSED A SELF-TEST. A WARNING MEMORY FULL MESSAGE WAS GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. THE DEVICE WAS TESTED AND DELIVERED A TEST SHOCK WITHOUT FAULT. AN ACCEPTABLE MEASUREMENT FOR THE TEST SHOCK WAS RECORDED. THE DEVICE POWERED OFF NORMALLY WITH A MEMORY FULL PROMPT AND A FLASHING GREEN STATUS LED. THE STATUS LEDS WERE WORKING INITIALLY DURING THE INVESTIGATION BUT THEN FAILED AS TESTING CONTINUED. IT CAN THEREFORE BE CONCLUDED THAT THE FAULT WAS INTERMITTENT IN NATURE. FURTHER INVESTIGATION CONCLUDED THAT THE FAULT CAN BE ATTRIBUTED TO A SHORT CIRCUIT BETWEEN THE GREEN AND RED STATUS LEDS DUE TO EXCESS SILVER PASTE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629404 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1