BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932565 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00056
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    June 22, 2011
    Report Date
    January 7, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS NEVER INSTALLED AFTER DISPATCH FROM HEARTSINE TECHNOLOGIES. A PAD-PAK WAS INSERTED INTO THE DEVICE AND IT WAS FOUND NOT TO POWER UP WHEN THE ON SWITCH WAS PRESSED, CONFIRMING THE REPORTED FAULT. AN INSPECTION OF THE DEVICE REVEALED THE MEMBRANE WAS NOT FITTED PROPERLY. THE MEMBRANE WAS REMOVED AND RE-FITTED PROPERLY AND THE DEVICE WAS THEN POWERING ON AND OFF CORRECTLY. 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 PATIENT INVOLVED IN THIS EVENT. THE DEVICE MALFUNCTIONED DUE TO A FAULTY ON/OFF SWITCH. 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
    33087 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1