Catalog Number 10101 |
Device Problem
Environmental Particulates (2930)
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Patient Problems
Headache (1880); Dizziness (2194)
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Event Date 02/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineer was dispatched to customer site.The catalytic decomp filter, iso-kf center ring and vacuum pump filter exhaust were replaced to resolve the haze/mist/vapor issue.Unit meets specifications and was returned to service on 02/15/2017.
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Event Description
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A customer reported a fluid leak and haze emitting from the sterrad® 100s sterilizer.Two healthcare worker (hcw¿s) experienced a headache and dizziness.The hcw¿s did not seek or receive any medical attention/treatment and are reported to be fine.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.There are no serious injuries reported with this event; however, this is being reported as a malfunction report subsequent to a serious injury.
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Manufacturer Narrative
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The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.
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Manufacturer Narrative
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Asp investigation summary: the investigation included a review of the device history record (dhr), functional analysis and system risk analysis (sra).The vacuum pump exhaust filter was returned and tested.The reason for the return of the vacuum pump exhaust filter was not confirmed.The catalytic decomp filter was returned and tested.The reason for the return of the catalytic decomp filter was not confirmed.The iso-kf center ring was returned and tested.The reason for the return of the iso-kf center ring was not confirmed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the assignable cause of the haze/mist/vapor issue is the vacuum pump exhaust filter, catalytic decomp filter and iso-kf center ring.The field service engineer replaced these parts and confirmed the sterrad® 100s.The unit was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.
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Search Alerts/Recalls
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