BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 2862943 · Received December 10, 2012

    Report

    Report Number
    2084725-2012-00092
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASP FIELD SERVICE ENGINEER ASSESSED THE UNIT ONSITE AND CONFIRMED THE ODOR/SMELL. A HOSE, PUSH-ON (B)(4) ID WAS REPLACED FOR A FLUID LEAK.

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULT: OIL RETURN HOSE. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, FAILURE MODE AND EFFECTS ANALYSIS, AND SYSTEM HAZARD AND USER MISUSE ANALYSIS. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND INDICATED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCED "ODOR/SMELLS" ISSUE. THE UNIT MET SPECIFICATION AT THE TIME OF ITS RELEASE. THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST 6 MONTHS (05/17/12 ¿ 11/13/12) DID NOT REVEAL A SIGNIFICANT TREND. THE COMPLAINT TRENDING FOR PROBLEM CODE ¿ODOR/SMELLS¿ IDENTIFIED A SIGNIFICANT TREND OVER THE PAST 12 MONTHS (SEPTEMBER 2012 ¿ AUGUST 2013). THIS RISK IS CONSIDERED AS LOW AS REASONABLY PRACTICAL. THE TRENDING FOR PROBLEM CODE ¿RESPIRATORY REACTION¿ (SEPTEMBER 2012 ¿ AUGUST 2013) REVEALED THE RISK IS CONSIDERED BROADLY ACCEPTABLE. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER ASSOCIATED WITH LEAKING OIL RETURN TUBING IS AT AN ACCEPTABLE LEVEL. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) DEFINES THE RISK AS LOW AS REASONABLY PRACTICAL FOR EXPOSURE TO ODOR OR ODORANTS. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. REVIEW OF THE TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND. AS A RESULT, ROOT CAUSE OR ASSIGNABLE CAUSE ANALYSIS COULD NOT BE PERFORMED. NO FURTHER ACTION IS REQUIRED; HOWEVER, THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A STRONG ODOR EMITTING FROM THE STERRAD 100S. THE HEALTHCARE WORKERS EXPERIENCED SYMPTOMS OF MINOR RESPIRATORY DISCOMFORT AND HEADACHES. THERE WAS NO MEDICAL TREATMENT FOR THE SYMPTOMS. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1