BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4792662 · Received May 18, 2015

    Report

    Report Number
    3004123209-2015-00550
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 19, 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
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN MARCH 2010 AND PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE 5TH OCTOBER 2014. INFORMATION FROM THE HISTORY LOG WOULD SUGGEST THE DEVICE MAY HAVE BEEN ATTACHED TO A PATIENT DUE TO THE DEVICE EXCEEDING THE TEN MINUTE TIME OUT. DURING THIS TIME, ON THE 3RD MAY 2013, INFORMATION FROM THE TECHNICAL LOG SHOWS THE DEVICE MAY HAVE BEEN ATTACHED TO A PATIENT DUE TO AN IN RANGE PATIENT IMPEDANCE BEING MEASURED DUE TO THE DEVICE EXCEEDING THE TEN MINUTE TIME OUT. 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)(4) 2014 AND THE (B)(4) 2015. AN INCREASE IN VOLTAGE WAS OBSERVED WHICH SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. THE DEVICE PERFORMED SUCCESSFUL SELF-TESTS BETWEEN 29TH MARCH 2015 AND THE LAST LOG ENTRY ON THE 15TH MAY 2015. IT IS REASONABLE TO CONCLUDE THAT DEVICES RETURNED FOR THE REPORTED FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS WOULD FURTHER SUGGEST 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.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE PAD UNIT POWERS ON WITHOUT MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321099 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRIALLATOR MKJ HEARTSINE TECHNOLOGIES LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1