BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1191173 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00590
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MINNTECH COR
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SOLUTION SPILL) - OTHER, CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE WAS UNABLE TO DETERMINE CAUSE OF FLOODING. THE FSE REPLACED THE PRINTER AS IT WAS ALSO REPORTED TO BE DAMAGED. THE FSE RAN SEVERAL TEST CYCLES. THE SYSTEM MEETS SPECS. UPON FOLLOW UP WITH THE FSE, THE FSE REPORTED THAT THE FLOODING WAS NOT DUPLICATED AND HE DID NOT REPLACE ANY PART TO ADDRESS THE REPORTED FLOODING. THE FLOODING HAS NOT OCCURRED SINCE. OTHER, THE FSE COULD NOT DUPLICATE THE FLOODING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BASIN OVERFLOW. THE UNIT WAS OVERFLOWING A MIXTURE OF WATER AND CIDEX OPA. ALSO, THE PRINTER WAS DAMAGED. THERE WERE NO PHYSICAL COMPLAINTS RELATED TO THE LEAK. THE ASP FIELD SVC ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPIC REPROCESSOR FEB MINNTECH COR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA