BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5384809 · Received January 22, 2016

    Report

    Report Number
    3004123209-2016-00049
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 9, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FIRST DATE RECORDED IN THE MEMORY LOG WAS 13TH JANUARY 2016 WHEN THE DEVICE RECORDED TWO MANUAL POWER UPS. AS THIS IS A 2006 DEVICE AND THE FIRST LOG ENTRY IS IN 2016, IT IS LIKELY THE MEMORY LOG WAS ERASED PRIOR TO THIS DATE. NO FURTHER LOG ENTRIES WERE RECORDED AFTER THIS DATE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE DID NOT POWER UP. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE WAS MANUALLY POWERED UP AND PASSED A SELF-TEST. INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT. THERE WERE NO TEN MINUTE MANUAL POWER UPS RECORDED IN THE HISTORY LOG. THE DEVICE WAS ALSO STRESS TESTED BETWEEN 0 AND 50 DEGREES CELSIUS WITH A KNOWN GOOD PAD-PAK AND THE RETURNED MEMBRANE FITTED FOR 48 HOURS. THE DEVICE DID NOT TURN ON OR DISPLAY ANY FAULT. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43705 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1