BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 532127 · Received March 10, 2004

    Report

    Report Number
    1450997-2004-04002
    Event Type
    Malfunction
    Date Received
    March 10, 2004
    Date of Event
    January 31, 2004
    Report Date
    March 8, 2004
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPCHOLE PROCEDURE OXYGEN LEVEL DROPPED BEFORE BRADYCARDIA STARTED. PRESSURE DROPPED. PT AND ADHESIONS. THE PT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS INSUFFLATOR HIF NORTHGATE TECHNOLOGIES INC. 6620 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention