BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS TRILOGY

    MDR report key: 2954093 · Received February 8, 2013

    Report

    Report Number
    2954093
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 8, 2013
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    WHILE IN USE THIS TRILOGY VENTILATOR ALARMED "VENT SERVICE REQUIRED" WITH AN ERROR CODE 344. THE VENTILATOR WAS RETURNED TO PHILIPS/RESPIRONICS FOR REPAIR. THE OXYGEN AND 202 PCA KIT WAS REPLACED, THE SOFTWARE WAS UPGRADED TO REV. 11.5, AND RECALIBRATION WAS PERFORMED. WE HAVE RECEIVED VERBAL INFORMATION FROM THE SERVICE DEPARTMENT STATING THAT THEY HAVE SEEN INTERMITTENT PROBLEMS LIKE THIS AND A HARDWARE UPDATE IS FORTHCOMING. TWO DEVICES AT THIS FACILITY ARE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53472 PHILIPS TRILOGY VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 202 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO