BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3994265 · Received July 23, 2014

    Report

    Report Number
    2518422-2014-01193
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE THIRD PARTY SERVICE CENTER RETURNED THE INTERNAL BATTERY TO THE MANUFACTURER FOR FURTHER EVALUATION. THE INTERNAL BATTERY WAS FOUND TO HAVE A LOW STATE OF HEALTH. THE MANUFACTURER CONCLUDES THAT THE ISSUE WITH THE INTERNAL BATTERY IS RELATED TO NORMAL WEAR ASSOCIATED WITH RECHARGEABLE BATTERIES. A REVIEW OF THE DEVICE'S MANUFACTURING/SERVICE RECORDS INDICATES THE RETURNED BATTERY IS THE ORIGINAL BATTERY INSTALLED BY THE MANUFACTURER WHEN THE DEVICE WAS RELEASED IN 09/2011.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. AN ISSUE WITH THE INTERNAL BATTERY WAS OBSERVED AND THE INTERNAL BATTERY WAS REPLACED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430983 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1