BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3040462 · Received February 11, 2013

    Report

    Report Number
    3004123209-2012-00492
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 20, 2013
    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
    SW
    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 INFORMATION OBTAINED FROM THE DEVICE SHOWED THAT THE DEVICE FAILED THE WEEKLY SELF-RUN TEST ON (B)(6) 2012, BECAUSE OF A LOW BATTERY. INVESTIGATION DID NOT CONFIRM A FAULT WITH THE DEVICE OR ANY COMPONENT IN THE DEVICE. DURING TESTING, THE DEVICE WAS SHOWN TO PERFORM TO SPECIFICATION. THE IDENTIFICATION OF THE LOW BATTERY FAULT MAY HAVE BEEN CAUSED BY EXTERNAL INFLUENCES SUCH THAT THE PAD-PAK MAY NOT HAVE BEEN SEATED CORRECTLY IN THE DEVICE. THERE MAY ALSO BE AN INTERMITTENT FAILURE OF THE BATTERY TERMINAL POGO PINS, ALTHOUGH INVESTIGATION COULD NOT REPLICATE A FAULT WITH THE POGO PINS. INVESTIGATION ALSO CONFIRMED THAT THE RETURNED PAD-PAKS FROM LOT 687 (USE UNTIL 07/2013) SHOWED SIGNS OF NORMAL USAGE AND THESE TOO PERFORMED T SPECIFICATION DURING TESTING. 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 PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS FLASHING RED AND THE DEVICE WAS EMITTING A LOW BATTERY WARNING. 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
    60490 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1