BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892575 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00696
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    June 27, 2010
    Report Date
    December 4, 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 INFO OBTAINED FROM THIS DEVICE INDICATED THAT THE DEVICE WAS FIRST INSTALLED ON (B)(6) 2008 AND SUCCESSFULLY CARRIED OUT WEEKLY SELF-TEST UNTIL THE FIRST FAILED SELF TEST ON (B)(6) 2010. THE USER WAS ALERTED TO ALL FAILURES BY THE RED STATUS INDICATOR BEING ILLUMINATED AND A BEEP. ALTHOUGH NO FAULT WAS FOUND THE CONCLUSION OF THE INVESTIGATION IS THAT THE LOW BATTERY WARNING WAS TRIGGERED BECAUSE THE PAD-PAK WAS DEPLETED TO THE POINT WHERE THE BATTERY MANAGEMENT SYSTEM IN THE DEVICE WAS TRIGGERED. THERE IS EVIDENCE THE DEVICE WAS KEPT IN AN INADEQUATE LOCATION WHERE IT WAS EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS. 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 THE STATUS INDICATOR WAS FLASHING RED AND THE DEVICE WAS EMITTING AN AUDIBLE BEEP. 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