BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002107 · Received February 11, 2013

    Report

    Report Number
    3004123209-2012-00507
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    July 7, 2011
    Report Date
    November 20, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A KNOWN GOOD PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE FROZE ON POWER-UP. THE DEVICE EVENTUALLY POWERED UP AND INDICATED IT HAD BEEN INSTALLED ON (B)(6) 2008 AND OPERATED UNTIL (B)(6) 2010. THE DEVICE FAILED TO SELF-TEST DUE TO A LOW BATTERY. 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. THE DEVICE IS PASSING AND THEN FAILING SELF TESTES WITH NEW PAD-PAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59528 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1