BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN I

    MDR report key: 3905203 · Received May 28, 2014

    Report

    Report Number
    2518422-2014-00875
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER REC'D INFO FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314858 GARBIN I VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1058180

    Patients

    Seq Age Sex Outcome Treatment
    1