BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932502 · Received January 23, 2013

    Report

    Report Number
    3004123209-2012-00463
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 4, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    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) 2009 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2012. THE INFORMATION OBTAINED FROM THE DEVICE SHOWED THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING ON (B)(6) 2012 AND CONTINUED CONSISTENTLY UP TO (B)(6) 2012. INVESTIGATION DID NOT CONFIRM THERE TO BE A FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. THE DEVICE SWITCHING ITSELF ON IS A KNOWN SYMPTOM OF A DAMAGED OR FAULTY MEMBRANE. ALTHOUGH IN THIS EVENT, THERE WAS NO FAULT MEASURED IT IS PROBABLE THAT DAMAGE HAS BEEN CAUSED TO THE MEMBRANE WHICH HAS CAUSED THE DEVICE TO SWITCH ON AUTOMATICALLY. A DEVICE SWITCHING ON AUTOMATICALLY HAS THE POTENTIAL TO CAUSE PREMATURE DEPLETION OF THE PAD-PAK (BATTERY). THE PAD-PAK (LOT A986) THAT WAS RETURNED WITH THE DEVICE WAS TESTED AND TESTING CONFIRMED THAT WHILST THE PAD-PAK HAD BEEN DEPLETED, IT HAD NOT BEEN FULLY DEPLETED. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED 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 IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IF LEFT UNDETECTED COULD RESULT IN THE BATTERY BECOMING DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33581 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1