BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5433642 · Received February 12, 2016

    Report

    Report Number
    3004123209-2016-00170
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    January 29, 2016
    Report Date
    February 19, 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). THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON (B)(6) 2009 AND PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO (B)(6) 2016. AN INCREASE IN VOLTAGE SUGGESTS A FRESH PAD-PAK WAS INSTALLED DURING THIS TIME. MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTES DURATION WERE OBSERVED BETWEEN (B)(6) 2016 AND (B)(6) 2016. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND PASSED A SELF-TEST, A MEMORY FULL WARNING WAS GIVEN AND THE STATUS LED CONTINUED TO FLASH GREEN. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS AND THE EXCESS CURRENT DRAIN MEASURED WOULD CONFIRM A FAILING MEMBRANE. THE FAULT WAS WITNESSED DURING THE INVESTIGATION. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. 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.

    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 SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91535 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1