A field service engineer was dispatched to the customer site.The catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the smoke/haze and odor/smells issue.Unit meets specifications and was returned to service.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze and odor/smells issue, and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release trending analysis of the smoke/haze and odor/smells issue was reviewed within the past six months and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the parts were not available for return and further analysis.The assignable cause of the smoke/haze and odor/smells issue is the catalytic converter, oil mist filter, and vacuum pump oil.The field service engineer replaced these parts and confirmed the sterrad® 100s was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.(b)(4).
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A customer reported an event of smoke and a "strong chemical odor" emitting from the sterrad® 100s sterilizer.Two healthcare workers (hcw) experienced eye irritation and "slight burning", headache, and nausea.The hcws did not seek or receive medical attention or treatment for their symptoms.An asp field service engineer was dispatched to assess the unit onsite.The hcws eye, neurological and gastro-intestinal symptoms resolved without medical treatment.However, this event is being reported as a malfunction subsequent to a serious injury.
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