BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 9132986 · Received September 30, 2019

    Report

    Report Number
    3004123209-2019-00329
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 1, 2019
    Report Date
    July 2, 2020
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2010. THE RANDOM NATURE OF THE EVENTS STORED IN THE MEMORY AND THE 10 MINUTE TIMEOUTS, WOULD SUGGEST THE DEVICE WAS SWITCHING ON AUTOMATICALLY. THESE MULTIPLE MANUAL POWER ONS WOULD HAVE RESULTED IN THE DEVICE MEMORY BECOMING FULL ON THE (B)(6) 2019. 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.

    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

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHING ON AUTOMATICALLY AND GIVING MEMORY FULL PROMPT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHING ON AUTOMATICALLY AND GIVING MEMORY FULL PROMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931627 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1