BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6081456 · Received November 7, 2016

    Report

    Report Number
    3004123209-2016-01632
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 21, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). THE USER FIRST INSTALLED THE PAD-PAK ON THE 31ST DECEMBER 2010 AND PERFORMED SELF-TESTS UP TO THE (B)(6) 2016. THE DEVICE RECORDS 27 MANUAL POWER UPS UNDER ONE MINUTE DURATION. THIS MAY INDICATE THE USER WAS REGULARLY POWER CYCLING THE DEVICE. THE DEVICE FAILED SEVERAL SELF-TESTS DUE TO A LOW BATTERY BETWEEN THE (B)(6) 2016. NO FURTHER LOG ENTRIES WERE RECORDED. A TEST PAD-PAK WAS INSTALLED AND THE DEVICE PASSED A SELF-TEST. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. A TEST SHOCK WAS DELIVERED WITHOUT FAULT AND AN ACCEPTABLE MEASUREMENT WAS RECORDED. INVESTIGATION WAS UNABLE TO REPLICATE OR FIND CONCLUSIVE EVIDENCE OF THE REPORTED FAULT. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. AS NO FAULT WAS FOUND WITH THE DEVICE IT IS REASONABLE TO CONCLUDE THAT THE MANUAL POWER UPS WERE DUE TO THE USER POWER CYCLING THE DEVICE. GIVEN THE AMOUNT OF TIME THE INITIAL PAD-PAK WAS INSTALLED PRIOR TO THE LOW BATTERY WARNING, THIS WOULD INDICATE A GENUINELY DEPLETED PAD-PAK. NO PAD-PAK WAS RETURNED FOR INVESTIGATION.

    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 SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735715 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1