BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 5359800 · Received January 12, 2016

    Report

    Report Number
    3004123209-2016-00021
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Date of Event
    January 5, 2016
    Report Date
    March 7, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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). ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 18TH JUNE 2015 AND PREFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE LAST LOG ENTRY ON THE (B)(6) 2016. THE PAD-PAK WAS REMOVED FOR APPROXIMATELY 9 DAYS DURING THIS TIME. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND PASSED A SELF-TEST. NO WARNINGS WERE GIVEN AND THE STATUS LED CONTINUED TO FLASH GREEN. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO COMPONENT FAILURE. THIS COMPONENT IS PART OF THE STATUS LED CIRCUITRY AND WHEN REQUIRED TURNS ON THE RED LED AND BEEPER. THIS LED TO THE GREEN STATUS LED FLASHING WHILE EMITTING A FAILURE CHIRP. THIS WOULD CONFIRM THE REPORTED FAULT.

    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

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE HAS GREEN FLASHING STATUS INDICATOR LIGHT WITH A CHIRPING SOUND AS IF DEVICE HAS DETECTED A FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18588 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1