BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 3102317 · Received April 30, 2013

    Report

    Report Number
    2518422-2013-00721
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE. DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, A FAILURE RELATED TO THE REMOTE ALARM CONNECTOR WAS OBSERVED. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE. CONCLUSION: DEVICE HAS BEEN EVALUATED AND REPAIRED BUT NOT RETURNED TO THE CUSTOMER, PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188001 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1040000

    Patients

    Seq Age Sex Outcome Treatment
    1