BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5433622 · Received February 12, 2016

    Report

    Report Number
    3004123209-2016-00206
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    February 9, 2016
    Report Date
    May 5, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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). NO INFORMATION WAS CONTAINED WITH THE DEVICE MEMORY LOG. THIS WOULD INDICATE THAT THE USER ACCESSIBLE MEMORY WAS ERASED. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE RESULTING IN AN EXCESS CURRENT DRAIN WHICH LIKELY LED TO PREMATURE DEPLETION OF THE RETURNED PAD-PAK. THE USER WAS ALERTED TO THE DEPLETED PAD-PAK WITH A LACK OF FLASHING GREEN STATUS LED, THIS WOULD CONFIRM A FAILING MEMBRANE. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO GREEN STATUS INDICATOR WITH AN IN DATE PAD-PAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92825 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1