BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNI-VENT

    MDR report key: 2439725 · Received January 28, 2012

    Report

    Report Number
    2242630-2011-00105
    Event Type
    Other
    Date Received
    January 28, 2012
    Report Date
    December 10, 2011
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(4) 2011. A MODEL 73X VENTILATOR (S/N (B)(4)) WAS RECALLED DUE TO THE POSSIBILITY OF INCORRECT TUBING. AN INSPECTION OF THE DEVICE REVEALED LOW PRESSURE TUBING IN AN APPLICATION WHERE HIGH PRESSURE TUBING WAS REQUIRED. THE TUBING WAS REPLACED, THE DEVICE WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO DEATH OR INJURY RESULTED FROM THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-VENT VENTILATOR BTL IMPACT INSTRUMENTATION, INC. 73X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other