MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 3052 WASHER

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injury, procedure delay, or cancellation occurred as a result of the reported event.The event occurred on a weekend after all surgical procedures had been completed for the week, no evacuation occurred.No smoke was observed by the user facility.A steris service technician arrived on-site, inspected the amsco 3052 washer, and confirmed the unit's air compressor overheated resulting in the user facility's smoke alarm to go off.The user facility's smoke alarm was located in close proximity to the amsco 3052 washer's air compressor.The technician replaced the air compressor, tested the unit, and confirmed it to be operating according to specification.No additional issues have been reported with the amsco 3052 washer.A review of complaints with the amsco 3052 washer indicated that this is an isolated issue.The air compressor subject of the reported event is being returned to steris for evaluation, a follow-up mdr will be submitted should any additional information be obtained.
Event or Problem Description
The user facility reported that the air compressor on their amsco 3052 washer overheated, causing the smoke alarm to go off in the facility.
Additional Manufacturer Narrative
The air compressor subject of the reported event was returned to steris for evaluation.The evaluation identified that the air compressor overheated due to a failure of the electric engine; however, the exact cause of the failure could not be determined.A review of complaint records indicates that this is an isolated event.No additional issues have been reported with the amsco 3052 washer.

• Brand Name: AMSCO 3052 WASHER
• Common Device Name: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• MDR Report Key: 6901626
• Report Number: 9680353-2017-00070
• Device Sequence Number: 807799
• Product Code: MEC
• UDI-Device Identifier: 00724995152055
• UDI-Public: (01)00724995152055(11)161205
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1