A field service engineer was dispatched to the customer site.The cap of the catalytic converter was replaced, and the oil mist filter was reseated to resolve the odor/smells issue.Unit meets specifications and was returned to service.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells 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 issue for the sterrad® 100nx 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/smells is potentially due to the cap of the catalytic converter and the oil mist filter.The asp field service engineer replaced and reseated the parts and confirmed the sterrad® 100nx met functional specifications after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 #: cmp(b)(4).
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Advanced sterilization products (asp) has investigated the complaints to support the rationale for the decision to cease reporting odor, mist, or haze events related to the sterrad® sterilizer vacuum subsystem.The issue is indicated in the product label warning as a known risk that occurs rarely.The probability of serious adverse health consequences is remote; therefore, asp has determined that the malfunction is no longer likely to cause or contribute to a serious adverse event if it were to recur.Asp has notified the u.S.Food and drug administration of the cease malfunction reporting decision, reference fda document number (b)(4).Asp complaint ref #: (b)(4).
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