BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN

    MDR report key: 2833582 · Received October 29, 2012

    Report

    Report Number
    2518422-2012-02139
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    March 26, 2012
    Report Date
    March 26, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, DAMAGE TO THE AC INLET CONNECTOR WAS OBSERVED. THE DEVICE'S AC INLET CONNECTOR WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GARBIN VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1058180

    Patients

    Seq Age Sex Outcome Treatment
    1