BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6101358 · Received November 15, 2016

    Report

    Report Number
    3004123209-2016-01627
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 17, 2016
    Report Date
    July 3, 2017
    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
    UK
    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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, (B)(4) ON THE (B)(4) 2010. THE DATA OBTAINED FROM THE DEVICE SHOWED EVIDENCE THAT THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY, RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING (B)(6) AND (B)(6) 2016. EXPERIENCE HAS SHOWN THAT IT IS REASONABLE TO CONCLUDE THAT THESE SYMPTOMS MAY 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752492 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1