BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY DETACHABLE BATTERY

    MDR report key: 2852439 · Received November 13, 2012

    Report

    Report Number
    2518422-2012-02291
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY WOULD NOT CHARGE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER AN ISSUE WITH THE DETACHABLE BATTERY CONNECTOR WAS OBSERVED WHICH PREVENTED THE DEVICE FROM CHARGING IT'S INTERNAL BATTERY. THE DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY DETACHABLE BATTERY VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1043570

    Patients

    Seq Age Sex Outcome Treatment
    1