BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH QUICKJET MANUAL JET VENTILATOR

    MDR report key: 1860272 · Received September 22, 2010

    Report

    Report Number
    1044475-2010-00119
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U INVESTIGATION REPORT WILL BE SENT WHEN INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE NEEDLE ON THE GAUGE IS BENT AND DRAGGING. WHEN NOT HOOKED UP, IT SETS AT 10PSI AND NOT ZERO. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH QUICKJET MANUAL JET VENTILATOR QUICKJET CBK TELEFLEX MEDICAL NA 3-37

    Patients

    Seq Age Sex Outcome Treatment
    1