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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® STERILIZER 100NX 1-DR STERRAD® EQUIPMENT

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ADVANCED STERILIZATION PRODUCTS STERRAD® STERILIZER 100NX 1-DR STERRAD® EQUIPMENT Back to Search Results
Catalog Number 10104
Device Problem Environmental Particulates
Event Date 07/23/2019
Event Type  Malfunction  
Manufacturer Narrative

A field service engineer was dispatched to the customer site. The oil mist filter cartridge and vacuum pump oil were replaced to resolve the smoke/haze issue. Unit meets specifications and was returned to service. 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). 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 smoke/haze issue 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 smoke/haze issue is the oil mist filter cartridge and vacuum pump oil. The field service engineer replaced these parts 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).

 
Event Description

A customer reported an event of smoke or haze emitting from the sterrad® 100nx sterilizer. There was no report of any injuries or human reactions. 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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Brand NameSTERRAD® STERILIZER 100NX 1-DR
Type of DeviceSTERRAD® EQUIPMENT
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer Contact
gabriela mclellan
33 technology drive
irvine , CA 92618
949453-639
MDR Report Key8849210
Report Number2084725-2019-00918
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number10104
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/20/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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