BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2503431 · Received March 19, 2012

    Report

    Report Number
    2518422-2012-00183
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 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

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO PT HARM OR INJURY REPORTED.

    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 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1