BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1664142 · Received April 21, 2010

    Report

    Report Number
    2150060-2010-00032
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    January 8, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPLACED RESERVOIR TANK WAS AN OLD DESIGN. THE OLD TANK DESIGN WAS ASSEMBLED (NON-MOLDED) AND CAN CRACK RESULTING IN LEAKAGE OVER TIME FURTHER LEADING TO FAILURE TO THE TEMPERATURE SUBSYSTEM. THEREFORE, THE OLD TANK ASSEMBLY (P/N 40-50464-001) FAILED WITH A KNOWN FAILURE MODE. A CAPA IPLEMENTED A NEW RESERVOIR TANK ASSEMBLY (P/N 90-54773-001).REVIEW OF THE SERVICE HISTORY FOR THIS UNIT SHOWS NO SIMILAR LEAK COMPLAINTS. THIS IS THE FIRST TIME THAT THE RESERVOIR TANK WAS REPLACED ON THE UNIT SINCE THE INSTALLATION DATE, 05/02/2007 OF THIS ASP AER UNIT. THE GRAPH FOR THE AER CPUY (COMPLAINTS PER UNIT YEAR) FOR THE PROBLEM CODE "LEAKING FROM RESERVOIR" IS BELOW THE UPPER CONTROL LIMIT AND IS A GRADUALLY DECREASING TREND.

    Additional Manufacturer Narrative · 1

    EVALUATION BY MFG: AN ASP FIELD SERVICE ENGINEER (FSE) FOUND THE AER RESERVOIR TANK LEAKING AT THE HEATER. THE FSE REPLACED THE RESERVOIR TANK, PERFORMED FUNCTIONAL TESTING ON THE AER SYSTEM. HE CHECKED THE SYSTEM FOR LEAKS, RAN A TEST CYCLE. THE SYSTEM MEETS ALL MANUFACTURE SPECIFICATIONS.

    Description of Event or Problem · 1

    PER (B) (4) ADVERSE EVENT REPORT, THIS LEAD DISLODGED AND WAS REPLACED WITH ANOTHER LINOX SD 65/18, (B) (4). ON 04/20/2010 - THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER'S RESERVOIR ON THEIR AUTOMATIC ENDOSCOPIC REPROCESSER (AER) WAS LEAKING AT THE HEATER. THERE ARE NO REPORTS OF INJURY OR CONTACT WITH THE DISINFECTANT. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE AER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1