BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 3140088 · Received May 29, 2013

    Report

    Report Number
    2518422-2013-00953
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND 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 OR THE 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. THIS REPORT IS BEING SUBMITTED AS PART OF A PROGRAM TO RETROSPECTIVELY REVIEW POSSIBLE DEVICE MALFUNCTIONS THAT DID NOT INVOLVE ANY INJURY, TO DETERMINE WHETHER THEY ARE REPORTABLE UNDER 21 CFR PART 803 AND THE MFR'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER 12-PHI-01.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR ALLEGING NO POWER. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234763 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1032802

    Patients

    Seq Age Sex Outcome Treatment
    1