BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P PAD PAK

    MDR report key: 6449102 · Received March 31, 2017

    Report

    Report Number
    3004123209-2017-00342
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 21, 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
    GM
    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) THE INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD ( MANUFACTURER ) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC ( IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231817 HEARTSINE SAMARITAN 300P PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1