BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300 P AND PAD PAK

    MDR report key: 2915226 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00264
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 5, 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
    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 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. ON (B)(6) 2012, THE DEVICE FAILED A WEEKLY SELF-TEST BECAUSE OF A LOW BATTERY AND SWITCHED TO FAULT MODE, WHICH THE CUSTOMER WOULD HAVE BEEN ALERTED TO WITH THE STATUS INDICATOR FLASHING RED AND THE DEVICE EMITTING AN AUDIBLE WARNING MESSAGE. THE LOW BATTERY WARNINGS BECAME CRITICAL AND THE PAD-PAK BECAME FULLY DEPLETED ON (B)(6) 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 A1220). PAD PAK (LOT A1220) HAD A USE UNTIL DATE OF 06/2016 BUT BECAME DEPLETED ON (B)(6) 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 300 P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1