BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 3902510 · Received May 7, 2014

    Report

    Report Number
    2518422-2014-00741
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION 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 MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILS TO CHARGE ITS BATTERIES. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276805 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040000

    Patients

    Seq Age Sex Outcome Treatment
    1