Model Number 10101 |
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 vacuum pump oil, catalytic converter and oil mist filter were 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 a "vapor seeping out" or a haze/mist emitting from the sterrad® 100s 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® 100s 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 vacuum pump oil, catalytic converter and oil mist filter.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.Asp complaint ref #: cmp-(b)(4).
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Search Alerts/Recalls
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