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

Model Number	10104-005
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 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 smoke/haze issue for the sterrad® 100nx unit was reviewed for the prior six months from open date and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." no parts were replaced in resolving this issue.The assignable cause of the smoke/haze is likely due to the oil mist filter.An asp service engineer instructed the biomed to adjust the oil mist filter, and the unit¿s status was confirmed as ¿now system is functioning normally.¿ the issue was resolved at the customer facility.Asp will continue to track and trend this issue.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 biomed reported an event of a ¿smoke¿ or haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.An asp service engineer provided remote support and instructed the biomed to adjust the oil mist filter to resolve the smoke/haze issue.The status of the unit was reported as ¿now system is functioning normally.¿ this event is being reported as a malfunction report subsequent to a serious injury.

• Brand Name: STERRAD® 100NX ALLCLEAR STERILIZER 1-DR
• Common Device Name: STERRAD® 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 ; 9495030264
• MDR Report Key: 13446912
• Report Number: 2084725-2022-00008
• Device Sequence Number: 12121795
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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
• Device Model Number: 10104-005
• Device Catalogue Number: 10104-005
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown