BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNI-VENT

    MDR report key: 2439713 · Received January 28, 2012

    Report

    Report Number
    2242630-2010-00075
    Event Type
    Other
    Date Received
    January 28, 2012
    Date of Event
    September 28, 2010
    Report Date
    October 30, 2010
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATE NOTIFIED: (B)(6) 2010. A MODEL 706 VENTILATOR (S/N (B)(4)) FAILED TO OPERATE TO SPECIFICATIONS. AN INSPECTION OF THE DEVICE REVEALED A BROKEN WIRE CONNECTION. THE CONNECTION WAS RESOLDERED, 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 CBK IMPACT INSTRUMENTATION, INC. 706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other