BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FUSOR 500ML PRESSURE INFUSOR

    MDR report key: 515212 · Received January 21, 2004

    Report

    Report Number
    1526863-2003-00145
    Event Type
    Malfunction
    Date Received
    January 21, 2004
    Date of Event
    January 1, 2003
    Report Date
    November 3, 2003
    Manufacturer
    MEDEX
    Product Code
    KZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE C-FUSOR COULDN'T KEEP UP THE PRESSURE. NO PT TREATMENT OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FUSOR 500ML PRESSURE INFUSOR PRESSURE INFUSOR KZD MEDEX NA 33C050014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN