BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 2223096 · Received August 10, 2011

    Report

    Report Number
    2518422-2011-00086
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER'S REPAIR CENTER WITH AN ALLEGATION THE DEVICE WAS AUDIBLY ALARMING AND HAD NO FLOW. THE DEVICE WAS NOT IN PT USE AND THERE WAS NO PT HARM OR INJURY. THE VENTILATOR WAS EVALUATED AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE WAS FOUND TO HAVE A LOOSE LEAF CHECK VALVE WHICH CAUSED AN INTERNAL LEAK AND LOSS OF FLOW. THE LEAF CHECK VALVE WAS REPLACED TO CORRECT THE PROBLEM. ALTHOUGH THE VENTILATOR WAS MANUFACTURED IN 2006, THE DEVICE HAD NEVER BEEN RETURNED FOR SERVICE OR PREVENTIVE MAINTENANCE. THERE WAS NO PT HARM OR INJURY. THE VENTILATOR AUDIBLY ALARMED TO ALERT THE CAREGIVER OF AN EVENT. A REVIEW OF THE MANUFACTURER'S ADVERSE EVENT DATABASE CONFIRMED THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH A LEAKING LEAF CHECK VALVE. NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE PLV 102B CBK RESPIRONICS, INC. 1003111

    Patients

    Seq Age Sex Outcome Treatment
    1