BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8602774 · Received May 13, 2019

    Report

    Report Number
    3004123209-2019-00171
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 30, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    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 TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2013. DURING THE INVESTIGATION, THE GREEN STATUS LED WAS NOT FLASHING, AS PER THE REPORTED FAULT. THE GREEN STATUS LED ON THE MEMBRANE WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN THE DEVICE DISPLAYING NO STATUS INDICATOR. THE FAULT COULD NOT BE REPLICATED WHEN THE MEMBRANE WAS REPLACED. THE STATUS LEDS ARE TESTED DURING H017-014-104 FINAL UNIT TEST, THE DEVICE SUCCESSFULLY PASSED FINAL UNIT TEST ON THE (B)(6) 2013. THIS WOULD THEREFORE INDICATE THE COMPONENT FAILED AFTER DISPATCH FROM HEARTSINE. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH ANOTHER DEVICE OF THE SAME MODEL.

    Description of Event or Problem · 0

    NO GREEN STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    NO GREEN STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396252 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1