BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 2001 ELECTRONIC INSUFFLATOR

    MDR report key: 52296 · Received November 26, 1996

    Report

    Report Number
    2522397-1996-00020
    Event Type
    Injury
    Date Received
    November 26, 1996
    Date of Event
    October 25, 1996
    Report Date
    November 26, 1996
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED CARDIO PULMONARY COMPROMISE DURING LAPAROSCOPIC PROCEDURE. APPROX 3 LITERS OF CO2 HAD BEEN INSTILLED INTO THE PT AT THE TIME OF THE EVENT. THE PT WAS RESUSCITATED AND SUFFERED NO ADVERSE CONSEQUENCES. THE PT DID NOT HAVE A HISTORY OF CARDIAC PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 2001 ELECTRONIC INSUFFLATOR ELECTRONIC LAPAROSCOPIC INSUFFLATOR HIF CABOT MEDICAL CORP. SYSTEM 2001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other