Initial reporter phone number: (b)(6).Asp field service engineer provided remote support, and the customer facility biomed confirmed that the odor/smells and mist/haze issues have been resolved.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells and mist/haze issue, and system risk analysis (sra).The device history record (dhr) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the odor/smells and mist/haze issues for the sterrad® 100s unit was reviewed for the prior six months from the event date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for further analysis.The assignable cause of the odor/smell and mist/haze is potentially due to the catalytic converter.The customer facility biomed replaced the part and confirmed the sterrad® 100s was restored to proper function.Asp will continue to track and trend this issue.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref#: (b)(4).
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