BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARTAIN 300P AND PAD PAK

    MDR report key: 7138581 · Received December 21, 2017

    Report

    Report Number
    3004123209-2017-01406
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    December 20, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY BY THE USER ON THE 4TH MAY 2011. THE DEVICE RECORDS MANUAL POWER UPS OF TEN MINUTES IN DURATION BETWEEN THE 20TH JULY 2013 AND 21ST SEPTEMBER 2016. INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED 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. THE DEVICE WAS RETURNED TO HEARTSINE TECHNOLOGIES AS PART OF THE CURRENT FSCA /RECALL, FDA REFERENCE Z-0124-2013. NO FAULT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918477 HEARTSINE SAMARTAIN 300P AND PAD PAK AUTOMED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES SAM

    Patients

    Seq Age Sex Outcome Treatment
    1