A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).
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H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist 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 haze/mist issue for the sterrad® 100nx unit 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 haze/mist issue is the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil.The field service engineer replaced these parts and confirmed the sterrad® 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).
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