Catalog Number 10104-007 |
Device Problem
Device Emits Odor (1425)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
Event Type
malfunction
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Event Description
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A customer reported an event of an ¿odor¿ or smell emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer was instructed to power off the unit and discontinue use.An asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a previous serious injury.
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Manufacturer Narrative
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A field service engineer was dispatched to the customer site.The adapter converter was replaced to resolve the odor/smells issue.Unit meets specifications and was returned to service.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.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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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 odor/smells issue, and system risk analysis (sra).The device history record (dhr) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the odor/smells issue for the sterrad® 100nx unit was reviewed from the manufacture date to the event date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the field service engineer (fse) noted the adapter converter was cracked, and the component further broke apart during removal.The fse provided a photo of the broken adapter converter for review.The failure was confirmed based on the photo review; however, no further analysis can be completed as the component was damaged during removal.The assignable cause of the odor/smell is likely due to the adapter converter.The asp field service engineer replaced the part and confirmed the sterrad® 100nx met functional specifications 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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