BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIR-200

    MDR report key: 437520 · Received January 10, 2003

    Report

    Report Number
    1221261-2003-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2003
    Report Date
    January 7, 2003
    Manufacturer
    LEVEL 1, INC.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SALES REP. FROM CONMED RECEIVED A REPORT FROM THE CUSTOMER STATING THAT WHEN THE CLINICIAN TURNED THE REGULATOR ON, THE FRONT DOOR CAME FLYING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIR-200 PRESSURE INFUSER KZD LEVEL 1, INC. HIR-200 20020004

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO