BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGN INC

    MDR report key: 1627793 · Received March 3, 2010

    Report

    Report Number
    1627793
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    April 23, 2009
    Report Date
    March 3, 2010
    Manufacturer
    VITAL SIGNS, INC
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PRESSURE BAG ON A-LINE DEFLATED WITHOUT CAUSE OR MISUSE. IT WAS WITNESSED BY RESPIRATORY THERAPIST (RT). DEVICE WAS SAVED BY RT DUE TO IMMEDIATE RESPONSE OF REPLACEMENT OF BAG. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGN INC PRESSURE BAG KZD VITAL SIGNS, INC * 835B

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR