BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 5388002 · Received January 25, 2016

    Report

    Report Number
    3004123209-2016-00096
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    January 21, 2016
    Report Date
    March 7, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) 2014 AND PERFORMED TO SPECIFICATION, UP TO THE FINAL LOG ENTRY ON (B)(6) 2016. A TEST PAD-PAK WAS INSTALLED AND THE DEVICE PASSED A SELF-TEST. THE INSTRUCTIONAL LEDS COMPLETED THE CORRECT SEQUENCE HOWEVER NO AUDIO PROMPTS WERE GIVEN. THIS CONFIRMS THE REPORTED FAULT. THE GREEN STATUS LED FLASHED THROUGHOUT. THE DEVICE WAS TESTED ON CALIBRATED EQUIPMENT AND DELIVERED A SHOCK WITHOUT FAULT. AN ACCEPTABLE MEASUREMENT WAS RECORDED. NO SPEECH PROMPTS WERE DELIVERED THROUGHOUT. THE CORRECT LED SEQUENCE WAS GIVEN. THE DEVICE WAS DISASSEMBLED FOR FURTHER INVESTIGATION. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO A POOR CONNECTION WITH THE SPEAKER CABLE. THE FAULT WAS WITNESSED UPON RETURN TO HEARTSINE AS THE DEVICE DID NOT PLAY SPEECH PROMPTS WHILE POWER CYCLED. THE FAULT COULD NOT BE REPLICATED UPON REINSTALLATION OF THE SPEAKER DURING TESTING.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO SOUND ON THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46522 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1