BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915255 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00456
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 18, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    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) 2010 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2012. THE INFO 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 UP TO (B)(6). INVESTIGATION DID NOT CONFIRM 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 ON THIS MEMBRANE VISUAL INSPECTION CONCLUDED SIGNIFICANT CORROSION OF THE USB CONTACTS AND SCREWS AND THE DEVICE LABELS WERE WRAPPED AND MISCOLOURED. THIS WOULD INDICATE THAT THE DEVICE HAS BEEN STORED OUTSIDE THE RECOMMENDED STORAGE CONDITIONS. STORAGE OF THE DEVICE OUTSIDE THE RECOMMENDED STORAGE CONDITIONS CAN DAMAGE THE MEMBRANE. IT IS PROBABLE IN THIS EVENT, THE MEMBRANE HAS BEEN DAMAGED, WHICH HAS CAUSED THE DEVICE TO SWITCH ITSELF ON. A DEVICE SWITCHING ITSELF ON HAS THE EFFECT OF FILLING THE MEMORY AND EVENTUALLY DEPLETING THE PAD PAK. TWO PAD-PAKS FROM LOT 462 WERE RETURNED AND TESTING CONFIRMED ONE TO HAVE HAD LITTLE USE AND THE OTHER WAS SIGNIFICANTLY DEPLETED. THE USE UNTIL DATE OF PAD-PAK LOT 462 WAS 07/2012. 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 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1