BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 14406156 · Received May 16, 2022

    Report

    Report Number
    2518422-2022-20662
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 28, 2022
    Report Date
    July 11, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959005150
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. DEVICE FAILED TESTING DURING OBM CALIBRATION, IT WOULD NOT GO PAST 80PSI STEPS. THE TECHNICIAN REPLACED THE INTERFACE PCA TO ADDRESS THE FAILURE. THE PRODUCT IDENTIFICATION LAB COULD NOT CONFIRM, OR DUPLICATE TEST FAILURE IDENTIFIED AT SERVICE. RISK: ON REVIEW OF THE TRILOGY PRODUCT FAMILY RISK ASSESSMENT, ER 2200179 VERSION 39, THE FAILURE DOESN'T CHANGE OR MODIFY THE RISK OF THE DEVICE. THE RISK ASSOCIATED IS COVERED UNDER HAZARD TAG INAP08. EVALUATION: PIL VISUALLY INSPECTED THE INTERFACE PCA AND DID NOT OBSERVE ANY VISUAL DEFECTS. PIL TECH REVIEWED THE TEST REPORTS SENT FROM SERVICES AND COULD NOT FIND A FAILURE ALLEGED IN THE COMPLAINT BY SERVICES. PIL TECH INSTALLED THE SUSPECTED INTERFACE PCA INTO THE TRILOGY 202 TEST UNIT AND OPERATED FOR APPROXIMATELY 1 HOUR WITHOUT ANY ISSUES OR ERRORS. PIL HAS DETERMINED THAT THE INTERFACE PCA OPERATES AS DESIGNED AND NO PROBLEM FOUND. THE MANUFACTURER CONCLUDES THAT INTERFACE PCA BOARD HAS BEEN SCRAPPED AS PER THE REQUIRMENTS SET FORTH IN WORK INSTRUCTIONS 8.4-1131 REV 6 AND DISPOSED OF ACCRODINGLY.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535893 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040007 00606959005150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown