BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 6135056 · Received November 30, 2016

    Report

    Report Number
    2518422-2016-04667
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR'S INTERNAL BATTERY FAILED TO CHARGE. AN ISSUE WITH THE DEVICE'S SENSOR BOARD WAS OBSERVED. THE DEVICE'S SENSOR BOARD WAS ALSO RETURNED TO THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY FOR FURTHER INVESTIGATION. THE ROOT CAUSE OF THE SENSOR BOARD FAILING WAS CAUSED BY TRANSDUCER (B)(4) TO BE OUT OF TOLERANCE CAUSED BY CONTAMINATION.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A FAILURE OF THE DEVICE TO CHARGE ITS INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785292 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1