BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3181466 · Received May 21, 2013

    Report

    Report Number
    3181466
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 21, 2013
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS INC.
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO ZERO THE INFLATION DEVICE, DIAL STOPPED AT 3 ATMOSPHERES (ATM) AND WOULD NOT GO TO ZERO. THE CATHETERIZATION DEPARTMENT SWITCHED THE PATIENT TO ANOTHER DEVICE. THERE WAS NO PATIENT HARM.======================MANUFACTURER RESPONSE FOR BRAUN INFLATION DEVICE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NO RESPONSE AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?USED TO MEASURE PRESSURE OF CONTRAST OR SALINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225411 * SYRINGE, BALLOON INFLATION MAV B. BRAUN INTERVENTIONAL SYSTEMS INC. 622510 61246742

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR