BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER, INC.

    MDR report key: 2132603 · Received June 10, 2011

    Report

    Report Number
    MW5020986
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPANY BIOSENSE WEBSTER, PRODUCT CABLES AND INTERFACE ADAPTORS. COMPANY DOES NOT PLACE CATALOG NUMBERS ON CABLES SO CABLES ARE HARD TO IDENTIFY. QUICK REFERENCE STERILIZATION CHART PROVIDED BY THE COMPANY LISTS CABLES BY CATALOG NUMBER AND THEN REFERS YOU TO THE RESTERILIZATION INFO SHEET. THERE IS NO PRODUCT DESCRIPTION ON THE QUICK REFERENCE STERILIZATION GUIDE AND CATALOG NUMBER IS NOT ON THE PRODUCT SO THE STERILE PROCESSING DEPT HAS NO WAY TO CONFIRM THEY ARE REFERENCING THE CORRECT INSTRUCTIONS. SEVERAL OF THE CABLES ARE ONLY RE-STERILIZABLE WITH ETHYLENE OXIDE, THE COMPANY HAS TWO DIFFERENT ETO STERILIZATION INSTRUCTIONS DEPENDING ON THE CABLE. THE ETO INSTRUCTIONS PROVIDED ARE AMBIGUOUS AND VARY FROM THE DEFAULT CYCLES SET BY THE ETO STERILIZER MFR. THE ONE PARTICULAR CABLE WE ARE STRUGGLING WITH IS PRODUCT NUMBER C6MR10MLTCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER, INC. ACCESSORY CABLES DRF BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1