BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1647100 · Received March 31, 2010

    Report

    Report Number
    2150060-2010-00021
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASP FIELD SERVICE ENGINEER (FSE) CONDUCTED AN ONSITE EVALUATION OF THE CUSTOMERS AER FINDING A LEAK IN THE RESERVOIR. THE FSE REPLACED THE RESERVOIR TO RESOLVE THE LEAKING. THE MACHINE MEETS MANUFACTURERS REQUIRED SPECIFICATION.

    Additional Manufacturer Narrative · 1

    EVALUATED BY MFG: 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 IMPLEMENTED A NEW RESERVOIR TANK ASSEMBLY (P/N 90-54773-001). REVIEW OF THE ACCOUNT HISTORY FOR THIS UNIT DOES NOT DEMONSTRATE A TREND FOR THIS SPECIFIC ISSUE. THE GRAPH FOR THE AER CPUY (COMPLAINTS PER UNIT YEAR) FOR THE PROBLEM CODE "LEAKING FROM RESERVOIR" DOES NOT DEMONSTRATE A TREND. ASP WILL CONTINUE TO MONITOR FOR MORE TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMERS CIDEX RESERVOIR ON THEIR AUTOMATICE ENDOSCOPIC RESERVOIR (AER) WAS LEAKING. THERE ARE NO REPORTS OF INJURY OR CONTACT WITH CIDEX. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO SERVICE THE AER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SYNCOPE AND WAS ADMITTED FOR EVALUATION. ALL DEVICE BASED TESTING WAS NOTED TO BE NORMAL. THE NEXT DAY, WHILE HAVING AN ECHOCARDIOGRAM, THE PATIENT WAS LYING ON THEIR LEFT SIDE AND RIGHT VENTRICULAR (RV) LOSS OF CAPTURE (LOC) WAS OBSERVED. AN X-RAY WAS PERFORMED AND THE RV LEAD APPEARED TO HAVE MOVED, IT WAS DETERMINED THAT A LEAD REVISION WOULD BE NECESSARY. DURING THE RV LEAD REVISION, THE STYLET WAS UNABLE TO BE FULLY INSERTED INTO THE LEAD, THEREFORE, THE RV LEAD WAS REMOVED. WHILE EXPLANTING THE RV LEAD, IT BECAME ENGAGED WITH THE RIGHT ATRIAL (RA) LEAD AND CHANGED THE LOOP IN THE LEAD. IT WAS DECIDED TO EXPLANT THE RA LEAD AS WELL. A NEW RA AND RV LEAD WERE SUCCESSFULLY IMPLANTED. IT IS NOT CLEAR IF THE LEAD WAS IMPLANTED IN THE ATRIAL OR VENTRICULAR POSITION.

    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