BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM

    MDR report key: 1715237 · Received June 9, 2010

    Report

    Report Number
    2084725-2010-00196
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE, AND SYSTEM HAZARD USE MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD 200 SYSTEM (SERIAL NUMBER (B)(4)) CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 200 DID NOT REVEAL A TREND FOR DAMAGE TO CUSTOMER DEVICE (THERE WERE TWO DAMAGED DEVICE COMPLAINTS FOR THIS HOSPITAL). TRENDING ANALYSIS FOR DAMAGE TO CUSTOMER DEVICE ISSUES ASSOCIATED TO THE STERRAD 200 DID NOT CONSTITUTE A SIGNIFICANT TREND. (B)(4). THERE WERE NO PARTS RETURNED FOR INVESTIGATION OF THE REPORT OF DAMAGE TO CUSTOMER DEVICE ASSOCIATED TO THE STERRAD 200. THE PROBE WAS NOT RECOMMENDED BY THE MANUFACTURER, FOR ANY TYPE OF STERILIZATION; HOWEVER, IT IS APPROVED FOR HIGH LEVEL DISINFECTION PROCESSES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: GENERAL ELECTRIC COMPANY ECHO PROBE - MODEL # T-739, SERIAL # UNKNOWN. (B)(4): DAMAGED DEVICE. THE STERRAD 200 USER'S GUIDE WARNS: KNOW WHAT YOU CAN PROCESS: BEFORE PROCESSING ANY ITEM IN THE STERRAD STERILIZER; MAKE SURE YOU KNOW HOW THE STERRAD STERILIZATION PROCESS WILL AFFECT THE ITEM. READ, UNDERSTAND, AND FOLLOW THE MEDICAL DEVICE MANUFACTURERS' INSTRUCTIONS FOR THEIR PRODUCTS. THE FOLDOUT CHART IN THIS GUIDE LISTS THE CERTAIN TYPES OF ITEMS AND MATERIALS THAT CAN BE SAFELY PROCESSED IN THE STERILIZER. THIS GUIDE IS NOT INTENDED TO REPLACE ANY MEDICAL DEVICE MANUFACTURERS INSTRUCTIONS. IF YOU HAVE QUESTIONS, OR IF YOU ARE IN DOUBT ABOUT THE MATERIALS IN YOUR DEVICES, CONTACT THE MEDICAL DEVICE MANUFACTURER OR YOUR ASP CUSTOMER REPRESENTATIVE FOR MORE INFORMATION. THE STERRAD 200 STERILITY GUIDE DOES NOT LIST THE GENERAL ELECTRIC COMPANY ECHO PROBE (MODEL # T-739) AS A COMPATIBLE DEVICE WITH THE STERRAD 200. THE CUSTOMER WILL BE NOTIFIED TO CONTACT THE DEVICE MANUFACTURER REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A GENERAL ELECTRIC COMPANY ECHO PROBE WAS DAMAGED AFTER A COMPLETED CYCLE IN THE STERRAD 200 STERILZER. THE DAMAGE WAS DESCRIBED AS "THE PAINT ON ITS CONNECTOR OF THE PROBE PARTIALLY CAME OFF." THE PROBE WAS POUCHED PRIOR TO PROCESSING. IT IS UNKNOWN WHERE THE DEVICE WAS POSITIONED IN THE CHAMBER. THE AGE OF THE PROBE IS UNKNOWN. THERE WAS NO INJURY REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 200 STERILIZATION SYSTEM STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1