BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915233 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00230
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 28, 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
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN 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) 2012. 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 IT IS PROBABLE THAT DAMAGE HAS BEEN CAUSED TO THE MEMBRANE, WHICH HAS AFFECTED THE DEVICE CAUSING IT TO SWITCH ITSELF ON AUTOMATICALLY. A KNOWN EFFECT OF A DEVICE SWITCHING ITSELF ON AUTOMATICALLY IS THE PREMATURE DEPLETION OF THE PAD PAK. TESTING OF THE RETURNED PAD PAK (LOT 707) CONFIRMED THAT IT WAS A FRESH PAD-PAK AND SHOWED NO EVIDENCE OF DEPLETION. THERE WAS NO OTHER PAD-PAK RETURNED WITH THIS DEVICE. 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