BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS RESERVOIR, JAPAN

    MDR report key: 1051264 · Received May 22, 2008

    Report

    Report Number
    1825511-2008-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    PLAINFIELD-LOX-RX
    Product Code
    BYJ
    PMA / PMN Number
    K993220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A TECH AT COVIDIEN'S TECHNICAL SUPPORT CENTER EVALUATED THE UNIT, AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE HELIOS OPERATING INSTRUCTIONS INCLUDE THE FOLLOWING WARNING: "USING A DRY CLOTH THAT IS CLEAN, WIPE AND FILL CONNECTOR DRY ON BOTH THE RESERVOIR AND PORTABLE UNITS BEFORE FILLING TO PREVENT FREEZING AND POSSIBLE EQUIPMENT FAILURE." "EXTREME COLD HAZARD. DO NOT PRESS OR DISTURB THE PLASTIC POPPET IN THE CENTER OF THE FILL CONNECTOR OF THE RESERVOIR. THIS WILL CAUSE A RELEASE OF LIQUID OXYGEN FROM THE FILL CONNECTOR."

    Description of Event or Problem · 1

    IT WAS REPORTED: THJ (COVIDIEN) RECEIVED NOTIFICATION FROM A LOCAL DEALER THAT LIQUID OXYGEN LEAKED FROM THE QUICK-CONNECT DURING THE PRIOR-TO-USE INSPECTION. NO PT WAS INVOLVED, AND NO INJURY WAS SUSTAINED DURING THIS INSPECTION. A TECH AT COVIDIEN'S TECHNICAL SUPPORT CENTER EVALUATED THE UNIT, AND COULD NOT DUPLICATE THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS RESERVOIR, JAPAN NONE BYJ PLAINFIELD-LOX-RX H-36

    Patients

    Seq Age Sex Outcome Treatment
    1