BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 LITER NIAGARA HIGH FLOW IRRIGATOR

    MDR report key: 144294 · Received January 13, 1998

    Report

    Report Number
    9681384-1998-00002
    Event Type
    Malfunction
    Date Received
    January 13, 1998
    Date of Event
    June 27, 1997
    Report Date
    January 9, 1998
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ACTUAL DEVICE EVALUATED. ADDRESS CORRECTION.

    Description of Event or Problem · 1

    "DOOR OF ONE PUMP BLEW OPEN WHEN PUMP WAS BEING SET UP PRIOR TO PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 LITER NIAGARA HIGH FLOW IRRIGATOR IRRIGATION FLUID PUMP KQT ALTON DEAN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other