BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD-PAK

    MDR report key: 7334286 · Received March 13, 2018

    Report

    Report Number
    3004123209-2018-00218
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 27, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    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). H3 OTHER TEXT: DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 15TH NOVEMBER 2013. DURING THE INVESTIGATION THE GREEN STATUS INDICATOR FAILED TO LIGHT AS PER THE REPORTED FAULT. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE FAULT WAS TRACED BACK TO A FAILURE OF THE GREEN STATUS LED. THE COMPONENT WAS REMOVED FROM THE MEMBRANE AND MEASURED OUT OF SPECIFICATION. THE STATUS LEDS WERE TESTED DURING PASSED FINAL UNIT TEST (H032-014-004) ON THE 15TH NOVEMBER 2013. THEREFORE, IT IS CONCLUDED THE GREEN LED FAILED AFTER DESPATCH 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

    END-USER ALLEGES THAT PAD UNIT'S STATUS INDICATOR DOES NOT WORK. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    END-USER ALLEGES THAT PAD UNIT'S STATUS INDICATOR DOES NOT WORK. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179032 HEARTSINE SAMARITAN 350P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1