MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER; STERRAD® EQUIPMENT

Catalog Number	10104002
Medical Device Problem Codes	Degraded (1153); Environmental Particulates (2930)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The oil mist filter was tightened to resolve the haze/mist issue.Unit meets specifications and was returned to service.(b)(6).Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of an oil mist emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer was advised to turn the unit off and leave the room.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
The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.(b)(4).
Additional Manufacturer Narrative
(b)(4).The investigation included a review of the device history record (dhr), trending analysis of the issue and system risk analysis (sra).Trending analysis of the reported issue was reviewed from december 2017 to june 2018 and no significant trend was observed.The sra shows the risk for a quality problem with no impact on safety to be "low." no parts were replaced to resolve the reported issue.Upon further follow-up and clarification from the customer, there was no report of any odor, smell, haze or mist emitting from the sterrad.The customer reported a loose oil mist filter.The assignable cause is likely due the oil mist filter.The field service engineer adjusted the part 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.(b)(4).

• Brand Name: STERRAD® 100NX STERILIZER
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7678260
• Report Number: 2084725-2018-00652
• Device Sequence Number: 11105195
• Product Code: MLR
• UDI-Device Identifier: 10705037014507
• UDI-Public: 10705037014507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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 Catalogue Number: 10104002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/24/2018; 09/14/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/11/2018; 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1