BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIR-202

    MDR report key: 437636 · Received January 10, 2003

    Report

    Report Number
    1221261-2003-00002
    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

    WHEN THE CLINICIAN TURNED THE UNIT ON, A PIECE OF THE DOOR COVER CAME FLYING OFF AND HIT THEM IN THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIR-202 PRESSURE INFUSER KZD LEVEL 1, INC. HIR-202 20020010

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO