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

Model Number	10104-007
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	Headache (1880); No Code Available (3191)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of an odorless vapor/smoke emitting from the sterrad® 100nx sterilizer and one healthcare worker (hcw) experienced irritation, burning, and itchiness in the eye.Upon follow-up, the hcw noted he took his contacts off to rinse and flush his eyes, and the reaction lasted 4 hours.The hcw also had a ¿light headache¿ which lasted 1 hour.However, the hcw did not receive medical attention/treatment for his symptoms.The customer was advised to clear the facility and shut down the unit until serviced.An asp field service engineer was dispatched to assess the unit onsite.The injuries reported were not considered serious as the symptoms resolved on their own without any medical treatment.However, this event is being reported as a malfunction subsequent to a serious injury.
Additional Manufacturer Narrative
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 adapter converter, catalytic converter, oil mist filter, 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).

• Brand Name: STERRAD 100NX STERILIZER ALLCLEAR 1-DR DUO
• Common Device Name: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 9578279
• Report Number: 2084725-2019-00010
• Device Sequence Number: 17735903
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 10104-007
• Device Catalogue Number: 10104007
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1