BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1203247 · Received October 17, 2008

    Report

    Report Number
    2084725-2008-00663
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND FLUID BEING BLOWN OUT OF THE PRESSURE RELIEF VALVE ON THE AIR COMPRESSOR. THE FSE REPLACED THE AIR VALVE, AND FUNCTION TESTED - ALL PASSED. THE SYSTEM MEETS MFG SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS LEAKING CIDEX OPA. THERE WERE NO REPORTS OF INJURIES. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    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