BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915129 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00766
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 17, 2010
    Report Date
    December 11, 2012
    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 MEMORY FROM THE RETURNED PAD DEVICE WAS REVIEWED AND MULTIPLE EVENTS CONFIRMED THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. ON INSPECTION IT WAS REVEALED THAT A COMPONENT CAPACITOR C161 HAD BECOME PARTIALLY DETACHED FROM THE PRINTED CIRCUIT BOARD AFFECTING THE ON/OFF CIRCUITRY. 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 PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IF LEFT UNDETECTED COULD RESULT IN THE BATTERY BECOMING DEPLETED.

    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