BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAKV

    MDR report key: 8702890 · Received June 17, 2019

    Report

    Report Number
    3004123209-2019-00223
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 1, 2019
    Report Date
    August 19, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK 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)2012 . DURING THE INVESTIGATION, THE GREEN STATUS LED WAS FLASHING GREEN ALONG WITH AN AUDIBLE CHIRP, AS PER THE REPORTED FAULT. THE RED STATUS LED ON THE MEMBRANE WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN A LEAKAGE CURRENT TO BEEPER BP1. THE FAULT COULD NOT BE REPLICATED WHEN THE RED STATUS LED WAS REMOVED FROM THE MEMBRANE. THIS WOULD CONFIRM A CURRENT LEAKAGE ACROSS THE COMPONENT HAD RESULTED IN THE REPORTED FAULT. THE STATUS LEDS ARE TESTED DURING H017-014-104 FINAL UNIT TEST, THE DEVICE SUCCESSFULLY PASSED FINAL UNIT TEST ON THE 7TH AUGUST 2012. 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 A SAM 350P.

    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

    DEVICE DISPLAYS GREEN STATUS INDICATOR BUT WITH BEEP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE DISPLAYS GREEN STATUS INDICATOR BUT WITH BEEP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496277 HEARTSINE SAMARITAN 300P AND PAD-PAKV AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1