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

Model Number	10104-005
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site and identified the oil mist filter screw had become loose.The fse tightened/adjusted the screw to resolve the odor/smell/smoke/haze issue.Unit meets specifications and was returned to service.(b)(6).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).
Event or Problem Description
A customer reported an event of a "fumes" or odor/smell/smoke/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.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smell/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 odor/smell/smoke/haze issue for the sterrad® 100nx 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." no parts were replaced as a result of this issue.The assignable cause of the odor/smell/smoke/haze issue is the oil mist filter screw.The field service engineer tightened the screw 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).

• Brand Name: STERRAD 100NX STERILIZER ALLCLEAR 1-DR
• Common Device Name: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 10747813
• Report Number: 2084725-2020-50256
• Device Sequence Number: 3657346
• Product Code: MLR
• UDI-Device Identifier: 10705037048670
• UDI-Public: 10705037048670
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10104-005
• Device Catalogue Number: 10104-005
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1026-1027-2013
• Patient Sequence Number: 1