BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKLEY VC-5

    MDR report key: 424200 · Received October 26, 2002

    Report

    Report Number
    424200
    Event Type
    Malfunction
    Date Received
    October 26, 2002
    Date of Event
    September 18, 2002
    Report Date
    October 23, 2002
    Manufacturer
    CABOT MEDICAL CORP
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN COMPLAINED THAT THE SUCTION MODULE STOPPED WORKING DURING PROCEDURE. THE CANNISTER AND SOCK WERE CHANGED BECAUSE THE SOCK WAS FULL. WHEN THE PHYSICIAN TRIED TO USE THE MODULE AGAIN IT WOULD NOT SUCTION. NEW EVACUATION TUBING WAS THEN USED WITHOUT SUCCESS. A NEW MODULE WAS SET UP AND USED TO FINISH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERKLEY VC-5 SUCTION MODULE JCX CABOT MEDICAL CORP BERKLEY VC5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other