BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPAP III ST-A WITH QUICKNAV - EUR GP2

    MDR report key: 2026320 · Received March 16, 2011

    Report

    Report Number
    3004604967-2011-00014
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K033276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER ENGINEERING INVESTIGATION BY THE MANUFACTURER. THE PRELIMINARY FINDINGS FOR THIS INVESTIGATION HAVE RESULTED IN NO FAULT FOUND UNDER NORMAL OPERATING CONDITIONS. IT IS POSSIBLE TO REPRODUCE THE REPORTED COMPLAINT BY REMOVING THE HOSE FROM THE HUMIDIFIER DURING OPERATION, RESULTING IN A "CHECK TUBE" ERROR MESSAGE ON THE LCD. ALTERNATIVELY, REMOVING THE HUMIDIFIER WHILST IN OPERATION WILL ALSO GIVE THE SAME ERROR MESSAGE. ONCE THE ERROR MESSAGE IS TRIGGERED, A SINGLE INTERMITTENT TONE IS SOUNDED AS AN ALARM AND THE MACHINE WILL STOP. THE ALARM AND NORMAL OPERATION OF THE DEVICE CAN BE RESET BY PRESSING THE START/STOP KEY ON THE USER INTERFACE. THE VPAP III SERIES IS DESIGNED TO SIGNAL TO THE USER A "CHECK TUBE" ERROR MESSAGE SHOULD THE HOSE OR THE HUMIDIFIER BECOME DISCONNECTED DURING OPERATION. THIS IS A TYPICAL SAFETY MITIGATION BY DESIGN. IN THIS CASE THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A VPAP III ST-A DEVICE DISPLAYED A "CHECK TUBE" ERROR MESSAGE THAT COULD NOT BE CLEARED FROM THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT WAS NEAR RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP III ST-A WITH QUICKNAV - EUR GP2 BZD RESMED LTD. 24135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention