BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 9853546 · Received March 19, 2020

    Report

    Report Number
    3004123209-2020-00069
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    January 29, 2020
    Report Date
    March 26, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST 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 · 0

    DEFECT FOUND AFTER INVVESTIGATION. MEMBRANE FAILURE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    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 SAM 300P WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND Q UALITY CHECKS AND TEST 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.QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2010.

    Description of Event or Problem · 1

    DEFECT FOUND AFTER INVESTIGATION. MEMBRANE FAILURE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319968 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1