BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4355790 · Received December 17, 2014

    Report

    Report Number
    2518422-2014-02311
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 19, 2014
    Report Date
    November 19, 2014
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CTR, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CTR ALLEGING A VENTILATOR FAILED TO POWER ON WITH AC POWER. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830301 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1