Model Number 10104 |
Device Problem
Smoking (1585)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineer was dispatched to the customer site and identified the oil mist filter retaining screw was loose.The screw was tightened to resolve the smoke/haze issue.Unit meets specifications and was returned to service.(b)(4).
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Event Description
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A customer reported an event of smoke/haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer stated the facility has ventilation and the unit was put out of service.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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The device history record (dhr) was reviewed for the sterrad® unit and no anomalies were observed that would contribute to the reported issue at the time of release.Aspcomplaint ref #: (b)(4).
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Manufacturer Narrative
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Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue and system risk analysis (sra).Trending analysis of the smoke/haze issue was reviewed from to and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were replaced as a result of the issue.The assignable cause of the smoke/haze issue is the oil mist filter screw.The field service engineer tightened 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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