BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5510097 · Received March 18, 2016

    Report

    Report Number
    3004123209-2016-00310
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    March 9, 2016
    Report Date
    May 12, 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
    SW
    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 SUCCESSFULLY INSTALLED ON THE (B)(6) 2009 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2015. DURING THIS TIME THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE WAS RECORDED BELOW THE MINIMUM RECOMMENDED STAND-BY TEMPERATURE OF 0 DEGREES CELSIUS WITH A LOW OF -3.8 DEGREES CELSIUS. ALSO DURING THIS TIME AN INCREASE IN VOLTAGE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. MULTIPLE MANUAL POWERS UP MAINLY OF TEN MINUTES DURATION WERE RECORDED BETWEEN (B)(6) 2015 AND (B)(6) 2016. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS AND EXCESS CURRENT DRAIN MEASURED DURING THE INVESTIGATION WOULD INDICATE A FAILING MEMBRANE. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. FURTHERMORE THERE WAS A SLIGHT FLUCTUATION OBSERVED ON THE POGO-PINS, HOWEVER THIS DID NOT AFFECT THE DEVICES ABILITY TO DELIVER THERAPY. 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 SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165912 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1