BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2641549 · Received June 29, 2012

    Report

    Report Number
    2518422-2012-01343
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER A FAILURE RELATED TO THE POWER SUPPLY WAS OBSERVED. 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 REQUIRED SERVICE. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1