BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8083627 · Received November 19, 2018

    Report

    Report Number
    3004123209-2018-00704
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 6, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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 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. 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

    MEMBRANE FAILURE DETECTED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    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. 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. 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 · 1

    MEMBRANE FAILURE DETECTED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923832 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1