BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6407161 · Received March 15, 2017

    Report

    Report Number
    3004123209-2017-00208
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 15, 2017
    Report Date
    May 4, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD ( MANUFACTRER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER) THERE WERE NO TEN MINUTE MANUAL POWER UPS RECORDED IN THE HISTORY LOG OR ANY EVIDENCE OF THE DEVICE SWITCHING ON AUTOMATICALLY. HOWEVER THE EXCESS CURRENT DRAIN MEASURED DURING THE INVESTIGATION, AND THE MEASUREMENTS TAKEN ON THE J11 CONNECTOR WOULD INDICATE A FAILING MEMBRANE. DURING THE COURSE OF THE INVESTIGATION THE GREEN STATUS LED WAS OBSERVED TO BE CONSTANTLY LIT BETWEEN FLASHES, THIS IS A FURTHER SYMPTOM OF MEMBRANE FAILURE.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE OBSERVED SWITCHING ON AUTOMATICALLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187306 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1