Model Number 10104-007 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineer was dispatched to the customer site.The oil mist filter assembly was replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.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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Event Description
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A customer reported an event of an "oil mist" or haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer was advised to turn the unit off and leave the room.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.
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Manufacturer Narrative
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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 for the prior six months from open date and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the oil mist filter was returned and tested.Physical inspection yielded no unusual findings or anomalies.The test cycle successfully completed with no errors or faults and no haze or mist was observed.The reason for the return of the oil mist filter could not be confirmed.The assignable cause of the haze/mist is likely due to the oil mist filter.The field service engineer replaced the part 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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Search Alerts/Recalls
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