BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892660 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00864
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    February 9, 2011
    Report Date
    December 18, 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

    THERE ARE TWO DATES RECORDED ON THE RETURNED PAD DEVICE, 4TH AND 5TH DECEMBER 1969 WHICH INDICATES A PROBLEM WITH THE REAL TIME CLOCK. THE COIN CELL WHICH SUPPLIES POWER TO THE CLOCK WAS TESTED AND NO FAULT WAS FOUND. THE REAL TIME CLOCK DATE AND TIME HAD BECOME CORRUPTED SOMETIMES AFTER DISPATCH ON (B)(4) 2011 FOR REASON UNK. IT WAS NOT POSSIBLE TO REPLICATE THE PROBLEM. THE CUSTOMER WAS ALERTED TO THE FAULT AT INSTALLATION. 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. THE DEVICE MALFUNCTIONED BECAUSE IT ISSUED A DEVICE SERVICE REQUIRED WARNING. A DEVICE EMITTING THIS WARNING MESSAGE HAS IDENTIFIED A FAULT WITH THE DEVICE AND IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO DELIVER THERAPY IF REQUIRED.

    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