BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892355 · Received November 30, 2012

    Report

    Report Number
    3004123209-2012-00545
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    December 9, 2011
    Report Date
    November 22, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. AFTER THIS DATE, THERE ARE MULTIPLE EVENTS WHERE THE USER MANUALLY SWITCHED ON THE DEVICE, BUT IT FAILED EACH TIME DUE TO LOW BATTERY. NO FAULT WAS FOUND, BUT THE BATTERY MANAGEMENT SYSTEM WAS TRIGGERED BECAUSE THE PAD-PAK WAS DEPLETED. THE PAD-PAK IN THE DEVICE WOULD APPEAR TO HAVE BEEN IN USE FOR THREE YEARS AND TWO MONTH AND WAS EITHER CLOSE TO OR PAST ITS EXPIRY. 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. THE DEVICE MALFUNCTIONED BECAUSE IT PASSES, THEN FAILS ITS SELF TEST WITH MULTIPLE PAD-PAKS.

    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