BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 5360355 · Received January 12, 2016

    Report

    Report Number
    3004123209-2016-00029
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Date of Event
    January 8, 2016
    Report Date
    February 9, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 13TH MAY 2015 AND PERFORMED TO SPECIFICATION UP TO THE 25TH JANUARY 2016. THE RETURNED PAD-PAK WAS INSTALLED. THE DEVICE WAS POWERED UP SUCCESSFULLY WHILE CYCLING THROUGH THE AUDIO PROMPTS, ALL MEMBRANE LEDS BECAME DIMLY ILLUMINATED. THE DEVICE POWERED OFF WITH NO WARNINGS GIVEN. NO STATUS LED WAS ACTIVE THROUGHOUT, THIS CONFIRMS THE REPORTED FAULT. THE DEVICE WAS TESTED ON CALIBRATED EQUIPMENT. THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT. AN ACCEPTABLE MEASUREMENT WAS RECORDED. THE DEVICE WAS THEN DISASSEMBLED FOR INVESTIGATION. INVESTIGATION FOUND THE FAULT WAS DUE TO MEMBRANE TAIL MISALIGNED. THE MEMBRANE TAIL WAS FOUND TO BE MISALIGNED WITHIN THE J11 CONNECTOR. THIS HAD CAUSED INSUFFICIENT CONNECTION BETWEEN THE TRACK ON THE MEMBRANE TAIL AND THE POINT OF CONTACT WITHIN J11. THE POOR CONNECTION RESULTED IN NO STATUS LED AND ALSO ABNORMAL ACTIVITY FROM THE MEMBRANE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO STATUS INDICATOR ON DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18587 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1