BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 5387993 · Received January 25, 2016

    Report

    Report Number
    3004123209-2016-00087
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    January 19, 2016
    Report Date
    February 9, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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) 2015 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2016. A TEST PAD-PAK WAS THEN INSTALLED. THE DEVICE WAS POWERED UP, THE SPEECH PROMPTS WERE NOT PROPERLY DELIVERED. THIS CONFIRMS THE REPORTED FAULT. THE GREEN STATUS LED FLASHED THROUGHOUT. THE DEVICE WAS TESTED ON CALIBRATED EQUIPMENT. THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT. AN ACCEPTABLE MEASUREMENT WAS RECORDED. THE DEVICE WAS THEN DISASSEMBLED FOR INVESTIGATION. INVESTIGATION FOUND THE FAULT WAS DUE TO THE DIGITAL SPEECH CHIP, PIN 12 NOT SOLDERED CORRECTLY. THIS COULD HAVE BEEN MAKING A MECHANICAL CONNECTION DURING THE DEVICE ASSEMBLY AND FINAL TEST IN ORDER TO DELIVER THE SPEECH PROMPTS CORRECTLY.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. SPEAKER, SOUND NOT FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48379 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1