BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIFLATOR

    MDR report key: 1203685 · Received September 26, 2008

    Report

    Report Number
    1203685
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INDEFLATOR DID NOT SHOW ATMOSPHERIC PRESSURE WITH INFLATION.====================== MANUFACTURER RESPONSE FOR BALLOON INFLATION SYSTEM,INTELLIFLATOR======================SUPERVISOR OF CATH LAB CALLED REP FOR MERIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIFLATOR BALLOON INFLATION SYSTEM MAV MERIT MEDICAL SYSTEMS, INC. * 4130328351 18:18

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR