BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7513650 · Received May 15, 2018

    Report

    Report Number
    3004123209-2018-00331
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 25, 2018
    Report Date
    June 20, 2018
    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
    MD, 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). H3 OTHER TEXT : DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE DEVICE WAS RELEASED WITH AN APPLICABLE CONCESSION, REFERENCE (B)(4). THIS CONCESSION ALLOWED FOR THE ADDITION OF A FOAM INSULATION STRIP TO PREVENT SHORTING BETWEEN CONTACTS ON THE SPEAKER. THIS CONCESSION WAS LIMITED TO THE 30TH AUGUST 2009. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 5TH AUGUST 2009. THE REPORTED PROBLEM, OF THE DEVICE SWITCHES ON AUTOMATICALLY, WAS ATTRIBUTED TO A MEMBRANE FAILURE. THE RANDOM NATURE OF THE EVENTS STORED IN THE MEMORY AND THE 10 MINUTE TIME OUTS, WOULD SUGGEST A FAILING MEMBRANE. EXPERIENCE HAS SHOWN THAT IT IS REASONABLE TO CONCLUDE THAT THESE SYMPTOMS MAY BE ATTRIBUTED TO A MEMBRANE FAILURE. THE RETURNED SAM 300P IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355825 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1