BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 1831905 · Received September 8, 2010

    Report

    Report Number
    2518422-2010-00096
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFR'S ADVERSE EVENT DATABASE FOR THE PAST FOUR YEARS, CONFIRMED THERE HAVE BEEN NO ADVERSE EVENTS CAUSED BY HIGH PRESSURE LIMIT POTENTIOMETER FAILURES. THE MFR CONCLUDES THE POTENTIOMETER WAS SUBJECTED TO STRESS OR IMPACT BEYOND ITS INTENDED DESIGN AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER RETURNED A VENTILATOR TO AN AUTHORIZED SERVICE CENTER FOR THE MFR'S REQUIRED PREVENTIVE MAINTENANCE. THE CUSTOMER MADE NO ALLEGATION OF DEVICE MALFUNCTION OR PT HARM. DURING THE PLANNED PREVENTIVE MAINTENANCE, A MALFUNCTION OF THE VENTILATOR'S HIGH PRESSURE LIMIT POTENTIOMETER WAS IDENTIFIED. THE MALFUNCTION CAUSED THE DEVICE TO FAIL TO AUDIBLY ALARM AND RELIEVE PRESSURE WHEN THE SET HIGH PRESSURE LIMIT WAS EXCEEDED. THE POTENTIOMETER WAS REPLACED TO CORRECT THE PROBLEM. THE POTENTIOMETER WAS EVALUATED BY THE MFR'S ENGINEERING DEPARTMENT AND WAS FOUND TO HAVE A DISLODGED REAR ENCLOSURE, WHICH CAUSED AN OPEN CIRCUIT CONDITION DUE TO EXCESSIVE MOVEMENT OF THE POTENTIOMETER SHAFT. THE MALFUNCTION APPEARS TO HAVE BEEN CAUSED BY SIGNIFICANT PHYSICAL FORCE (UNIT WAS DROPPED OR STRUCK) APPLIED TO THE FRONT OF THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE PLV-100 CBK RESPIRONICS, INC. 35006

    Patients

    Seq Age Sex Outcome Treatment
    1