BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 3172320 · Received June 5, 2013

    Report

    Report Number
    2518422-2013-01090
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER'S QUALITY ASSURANCE LAB FOR INVESTIGATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE. THE MALFUNCTION OF THE POWER SUPPLY WOULD RESULT IN THE FAILURE OF THE DEVICE TO OPERATE ON AC POWER OR TO CHARGE ITS INTERNAL BATTERY. THIS PARTICULAR MALFUNCTION FOR THE POWER SUPPLY HAS ONLY BEEN REPORTED ON DEVICES THAT ARE BEING SOLD INTERNATIONALLY FOR USE WITH 220 VOLT POWER SOURCES.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR WOULD NOT POWER ON. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249150 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1032800

    Patients

    Seq Age Sex Outcome Treatment
    1