BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1686152 · Received May 13, 2010

    Report

    Report Number
    2150060-2010-00042
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASP FIELD SERVICE ENGINEER (FSE) VERIFIED THE CUSTOMER COMPLAINT AND FOUND A SKINNER VALVE LEAKING. THE FSE COULD NOT FIND EVIDENCE OF ANOTHER LEAK. THE FSE RAN FOUR STANDARD CYCLES AND STATED THAT THE AER MEETS MANUFACTURER SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    BURNING EYES. THE CIDEX OPA IFU STATES IN PART: WARNING:AVOID EXPOSURE TO ORTHO-PHTHALALDEHYDE VAPORS, AS THEY MAY BE IRRITATING TO THE RESPIRATORY TRACT AND EYES. MAY CAUSE STINGING SENSATION IN THE NOSE AND THROAT, DISCHARGE, COUGHING, CHEST DISCOMFORT AND TIGHTNESS, DIFFICULTY WITH BREATHING OR HEADACHE. MAY AGGRAVATE A PRE-EXISTING ASTHMA OR BRONCHITIS CONDITION. IN CASE OF ADVERSE REACTIONS FROM INHALATION OF VAPOR, MOVE TO FRESH AIR. IF BREATHING IS DIFFICULT, OXYGEN MAY BE GIVEN BY QUALIFIED PERSONNEL. IF SYMPTOMS PERSIST, SEEK MEDICAL ATTENTION. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, FAILURE MODE EFFECTS ANALYSIS, THE SYSTEM HAZARD AND USER MISUSE ANALYSIS AND THE HEALTH HAZARD EVALUATION. THE DHR FOR THIS AER UNIT (SN (B)(4)) WAS REVIEWED AND REVEALED AND NO ISSUES WERE NOTED. THE SERVICE AND COMPLAINT HISTORY FOR THE ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER DID NOT REVEAL A SIGNIFICANT TREND. WITHIN THE PAST SIX MONTHS (NOVEMBER 2009 - APRIL 2010), THIS UNIT DOES SHOW SIMILAR LEAK ISSUES, BUT NOT DUE TO A FLOAT SWITCH INSTALLED IMPROPERLY. THUS, THERE IS NOT A SIGNIFICANT TREND. TRENDING ANALYSIS FOR FLUID LEAK ISSUES ASSOCIATED TO THE ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER OVER THE PAST SIX MONTHS (FROM NOVEMBER 2009 TO APRIL 2010) SHOWS NO SIMILAR ISSUES WITH THE UNIT. ADDITIONALLY, THERE IS NO TREND OBSERVED WITH THE SAME PART BEING REPLACED. THE CPUY (COMPLAINTS PER UNIT YEAR) FOR THE PROBLEM CODE "FLUID LEAK" WAS COMPLETED FOR DECEMBER 2009 THROUGH NOVEMBER 2010. THE TREND LINE LIES BELOW THE CALCULATED UPPER CONTROL LIMIT. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) FOR THE AER, ASSOCIATED TO SPILLS / LEAK FAILURES IS BELOW THE THRESHOLD OF 100. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WAS REVIEWED AND THE INITIAL RISK NUMBERS FOR USER REPEATED EXPOSURE HAZARDS WERE ALL 4 OR LOWER, WHICH WOULD BE CATEGORY I, OR "BROADLY ACCEPTABLE RISK." THE HHE (HEALTH HAZARD EVALUATION) FOR USERS COMPLAINT OF SYMPTOMS SUCH AS SHORTNESS OF BREATH, COUGHING, DIZZINESS, AND HALLUCINATIONS WAS REVIEWED. THE HAZARD INDEX WAS FOUND TO BE 3 OR LOWER, INDICATING NEGLIGIBLE RISK. THE HHE (HEALTH HAZARD EVALUATION) FOR COMPLAINTS OF "HEADACHES" FOR CIDEX OPA, DISOPA WAS PERFORMED. THE HAZARD INDEX WAS FOUND TO BE 3 OR LOWER, INDICATING NEGLIGIBLE RISK. ONE OF THE HEALTHCARE WORKERS REPORTED EXPERIENCING BURNING EYES FOR TWO DAYS. THERE WAS MINIMAL REACTION DUE TO EXPOSURE TO THE DISINFECTANT. THE SYMPTOMS HAD SUBSIDED AND NO MEDICAL ATTENTION WAS SOUGHT. THE EVALUATION WAS COMPLETED BY THE ASP FIELD SERVICE ENGINEER (FSE). THE FSE VERIFIED THE FAILURE. THE ISSUE WAS RESOLVED BY REPLACING THE SKINNER VALVE. THE TRENDING SHOWS THAT THE FAILURE IS NOT SIGNIFICANT AND THE RISK ASSOCIATED WITH THE FAILURE OF THE SKINNER VALVE IS LOW.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEIR AER WAS LEAKING A "BLUE FLUID" ONTO THE FLOOR FROM UNDERNEATH THE UNIT. THE UNIT WAS ASSESSED BY AN ASP FIELD SERVICE ENGINEER.

    Description of Event or Problem · 1

    A HCW REPORTED EYE IRRITATION AND BURNING EYES WHICH LASTED FOR TWO DAYS. NO MEDICAL TREATMENT WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CIDEX