BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892394 · Received November 30, 2012

    Report

    Report Number
    3004123209-2012-00174
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 16, 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 11/2010 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO 08/2012. 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 08/15/2012 AND CONTINUED CONSISTENTLY UP TO 09/15/2012. INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE DEVICE MEMBRANE. THIS FAULT CAUSED THE DEVICE TO SWITCH ON AUTOMATICALLY, WHICH CAUSED THE EARLY DEPLETION OF THE PAD PAK (LOT 663). PAD PAK (LOT 663) HAD A USE UNTIL DATE OF 06/2013, BUT BECAME DEPLETED ON 09/16/2012. 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