BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5352977 · Received January 8, 2016

    Report

    Report Number
    3004123209-2015-01693
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 18, 2015
    Report Date
    January 29, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE (B)(6) 2011 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2016. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE SUCCESSFULLY PASSED A SELF-TEST DURING A MANUAL POWER CYCLE. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. THE DEVICE WAS TESTED ON CALIBRATED EQUIPMENT. THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT. AN ACCEPTABLE MEASUREMENT WAS RECORDED. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION. INVESTIGATION WAS UNABLE TO REPLICATE OR FIND ANY EVIDENCE OF THE REPORTED FAULT. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE HISTORY LOG AND DURING TESTING AT HEARTSINE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. UNIT POWERS ON BY ITSELF W/O MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12681 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1