BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932496 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00043
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    May 27, 2011
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE ONLY TWO EVENTS RECORDED ON THE PAD DEVICE MEMORY. THE TWO EVENTS ARE ON (B)(6) 2011. THIS INDICATES THE MEMORY WAS ERASED ON OR BEFORE "(B)(6) 2011". THE RETURNED DEVICE WAS FOUND TO POWER UP AND OFF WHEN A PAD-PAK WAS INSERTED BUT IT WOULD NOT SWITCH ON AGAIN, CONFIRMING THE REPORT. THOUGH NO FAULT WAS FOUND WITH THE PAD OR PAD-PAK THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE DEVICE WOULD NOT POWER-ON AND THE STATUS INDICATOR IS PERMANENTLY LIT. 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
    33368 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1