BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1193360 · Received October 7, 2008

    Report

    Report Number
    2084725-2008-00644
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FACILITY BIOMED ADVISED THE CUSTOMER THAT THE RESERVOIR WAS TOTALLY FULLY WAY OVER THE 5 GALLONS. HE EMPTIED THE RESERVOIR WITH THE SERVICE BOX. THEY FILLED THE RESERVOIR WITH 5 GALS THEN THE DISPLAY READ E03, AND THE RESERVOIR WAS EMPTY. THE BIOMED SUGGESTED THAT THE CUSTOMER CHECK THE WASTE VALVE. HE TESTED THE UNIT WITH WARM WATER AND FILLED THE BASIN, THEN THE RESERVOIR AND ALLOWED THE WATER TO SOAK FOR A FEW MINUTES TO DISLODGE ANYTHING, WHICH MAY BE BLOCKING THE FLOAT SWITCH SINCE IT DID NOT GIVE E01 WHEN THE TANK WAS OVER 5 GALS. THE BIOMED SUGGESTED THAT THE CUSTOMER MARK THE TANK AT THE 5 GAL LEVEL TO EASILY VIEW THE TANK LEVEL. UPON ASP FOLLOW UP, THE UNIT IS WORKING WITHOUT FURTHER ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE CLEAR, MESH TUBE IN FRONT OF THE RESERVOIR WAS LEAKING CIDEX. CUSTOMER STATED THAT THERE WAS NO ERROR MESSAGE. SHE STATED THAT WHEN SHE RAN DISINFECT AND WASH SEPARATELY, IT DID NOT LEAK, ONLY WHEN IT RAN TOGETHER. THERE WERE NO REPORTS OF PHYSICAL COMPLAINT RELATED TO THE LEAK. THE FACILITY BIOMED ASSISTED THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC ENDOSCOPE REPROCESSOR AER EQUIPMENT FEB MINNTECH CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA UNKNOWN CIDEX