BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932589 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00130
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    October 5, 2008
    Report Date
    January 10, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF TEST ON (B)(6) 2008 AND AGAIN ON (B)(6) 2008. IT APPEARS THE DEVICE WAS LEFT IN THE FAULT MODE UNTIL (B)(6) 2009. THE DEVICE THEN PERFORMS AS EXPECTED FROM THEN TILL THE NEXT SELF TEST FAIL ON (B)(6) 2010. AGAIN THERE IS A GAP IN THE INFORMATION UNTIL (B)(6) 2010 BUT THE PAD-PAK IS REPLACED AND OPERATES UNTIL (B)(6) 2010. AFTER THIS DATE THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. THERE IS SIGNIFICANT CORROSION IN THE DEVICE AND IT IS IN POOR CONDITION INDICATING THE DEVICE IS BEING STORED IN A LOCATION WHERE IT IS EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS. THIS IS KNOWN TO HAVE A DETRIMENTAL EFFECT ON THE DEVICE MEMBRANE AND IS CONSIDERED LIKELY TO BE THE ROOT OF THE PROBLEMS WITH THIS DEVICE. 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 PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS NOT ILLUMINATED OR FLASHING. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33611 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1