BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 9294678 · Received November 8, 2019

    Report

    Report Number
    3004123209-2019-00393
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 24, 2019
    Report Date
    January 6, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE 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 3RD MAY 2013. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT OF ¿FLASHING GREEN AND BEEPING¿. THE FAULT WAS CONFIRMED DURING THE INVESTIGATION AND WAS TRACED BACK TO EXCESS SILVER PASTE WHICH HAD CAUSED A PARTIAL SHORT CIRCUIT BETWEEN THE ANODE AND CATHODE OF THE RED STATUS LED. THE SHORT CIRCUIT HAD RESULTED IN THE INITIATION OF THE BEEPER ALONGSIDE A FLASHING GREEN STATUS LED AS PER REPORTED FAULT. THIS WOULD ALSO ACCOUNT FOR THE FAILURE OF THE RED STATUS INDICATOR TO ILLUMINATE IN FAULT MODE AS WITNESSED DURING THE INVESTIGATION. THE STATUS LED¿S ARE TESTED DURING H017-014-104 FINAL TEST. THIS WOULD SUGGEST THAT THE SHORT CIRCUIT WAS INTERMITTENT IN NATURE AND CAUSED AS A RESULT OF AN OVER APPLICATION OF SILVER PASTE DURING THE MANUFACTURING PROCESS. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THIS CONFIRMED THE FAULT ON THE RETURNED MEMBRANE. 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

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE DEVICE IS BEEPING EVEN THOUGH THE INDICATOR LIGHT IS FLASHING GREEN.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE DEVICE IS BEEPING EVEN THOUGH THE INDICATOR LIGHT IS FLASHING GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088563 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1