BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6731606 · Received July 21, 2017

    Report

    Report Number
    3004123209-2017-00726
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    July 5, 2017
    Report Date
    August 10, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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).

    Description of Event or Problem · 0

    NO PATIENT INVOLVED. MEMORY FULL PROMPT.

    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 25TH FEBRUARY 2010. THE DATA OBTAINED FROM THE DEVICE SHOWED EVIDENCE THAT THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY FOR 10 MINUTE DURATIONS BETWEEN 20TH JULY 2014 AND 15TH OCTOBER 2014. THE DEVICE WAS STILL IN FAULT MODE ON 26TH OCTOBER WHEN INFORMATION FROM THE HISTORY LOGS SHOWS AN INCREASE IN VOLTAGE SUGGEST A FURTHER PAD-PAK WAS INSTALLED AND THE DEVICE PASSED A SELF TEST DURING A MANUAL POWER CYCLE. THE DEVICE SUCCESSFULLY PREFORMED LL WEEKLY AUTO SELF TESTS UP TO 10TH MAY 2015. THE DATA OBTAINED FROM THE DEVICE SHOWED EVIDENCE THAT THE DEVICE WAS MULTIPLE PREFORMING MANUAL POWER UPS FOR 10 MINUTE DURATIONS BETWEEN 10TH MAY 2015 AND THE LAST LOG ENTRY OF THE 27TH FEBRUARY 2017. AS A RESULT OF THE MULTIPLE POWER UPS THE DEVICE MEMORY BECAME FULL ALSO SUGGESTING THE DEVICE WAS SWITCHING ON AUTOMATICALLY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511503 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1