BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8407576 · Received March 11, 2019

    Report

    Report Number
    3004123209-2019-00098
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    March 1, 2019
    Report Date
    July 22, 2019
    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
    US
    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)2017. UPON RECEIPT OF THE DEVICE AT HEARTSINE, THE PAD CLOCK WAS FAILING TO INCREMENT AND DISPLAYED A NONSENSICAL TIME AND DATE. THIS WOULD INDICATE AN RTC FAULT. THE COIN CELL WAS MEASURED AND FOUND TO BE DEPLETED WITH THE COIN CELL VOLTAGE BEING SIGNIFICANTLY BELOW 3V. THE USER WOULD HAVE BEEN ALERTED BY THE ABSENCE OF THE GREEN STATUS LED AS THE BT1 COIN CELL PROVIDES THE POWER FOR THE STATUS LED DRIVE CIRCUITRY. THE COIN CELL WAS REPLACED AND THE PAD CLOCK WAS THEN SUCCESSFULLY RESYNCHRONISED. THE DEVICE WAS THEN TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS AND DISPLAYED NO FAULTS. THE RTC FAILURE IS NOT A CRITICAL FAILURE AND DID NOT AFFECT THE DEVICES ABILITY TO DELIVER THERAPY AS DEMONSTRATED DURING THE INVESTIGATION. THE GREEN STATUS INDICATOR WOULD HAVE REMAINED EXTINGUISHED AFTER THE DEPLETION OF THE COIN CELL. AS THE DEVICE WAS CONFIRMED TO HAVE PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE (B)(6)2017 THE COIN CELL WOULD HAVE BECOME DEPLETED AFTER THIS TIME. THE RETURNED SAM 300 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

    NO STATUS INDICATORS SEEN ON DEVICES. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    NO STATUS INDICATORS SEEN ON DEVICES. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203698 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1