BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2503389 · Received March 19, 2012

    Report

    Report Number
    2518422-2012-00258
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE¿S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THERE WAS NO PT HARM OR INJURY REPORTED. THE VENTILATOR WAS FOUND TO AUDIBLY AND VISUALLY ALARM, AS DESIGNED. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER (B)(4).

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING AN ALARM RELATED TO THE BATTERY OCCURRED. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 100 VENTILATOR, CONTINOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1054655

    Patients

    Seq Age Sex Outcome Treatment
    1