BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4812019 · Received May 25, 2015

    Report

    Report Number
    3004123209-2015-00579
    Event Type
    Malfunction
    Date Received
    May 25, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 10, 2015
    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
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2010 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2012. THE DATA OBTAINED FROM THE DEVICE SHOWED EVIDENCE THAT THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY, RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING BETWEEN (B)(6) 2012 AND THEN BETWEEN (B)(6) 2013 AND THE LAST LOG ENTRY ON THE (B)(6) 2015. THE PAD-PAK BECAME DEPLETED DURING THIS TIME AND A FURTHER PAD-PAK WAS INSTALLED WHICH ALSO BECAME DEPLETED. IT IS REASONABLE TO CONCLUDE THAT DEVICES RETURNED FOR THE REPORTED FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS AND THE EXCESS CURRENT DRAIN WOULD CONFIRM A FAILING MEMBRANE. 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.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THE DEVICE WAS MALFUNCTIONED AS THE DEVICE SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338379 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1