BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915210 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00847
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    February 20, 2011
    Report Date
    December 17, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF-TEST ON (B)(6) 2011 CAUSED BY A LOW BATTERY. THE USER WAS ALERTED TO THE PROBLEM BY THE RED LED STATUS INDICATOR BEING LUMINATED AND AN AUDIBLE BEEP. ON INSPECTION OF THE PAD DEVICE AN INCONSISTENT VOLTAGE MEASUREMENT WAS FOUND WHICH WOULD INDICATE A FAULT WITH THE POGO-PINS. 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1