BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892546 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00563
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    September 28, 2011
    Report Date
    November 26, 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

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. ON (B)(6), 34 MANUAL EVENTS ARE RECORDED AND 9 OF THESE MEASURED A LOW BATTERY VOLTAGE. THIS WOULD PRODUCE THE REPORTED PROBLEM, IE, DEVICE SERVICE REQUIRED MESSAGES. ON INSPECTION OF THE BATTERY EVENTS, THE SHOCK BUTTON WAS PRESSED ON EACH OF THE 9 EVENTS. NO FAULT WAS FOUND WITH THE RETURNED DEVICE. THE PROBLEM OF THE WARNING MESSAGE BEING ISSUED COULD BE REPLICATED BY PRESSING THE ON/OFF ANS SHOCK BUTTONS SIMULTANEOUSLY. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS EMITTING THE "DEVICE SERVICE REQUIRED" WARNING PROMPT. 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