MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; AMSCO 600 STEAM STERILIZER

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported observing a small flame on their amsco 600 sterilizer.The flame was quickly extinguished.No report of injury.
Additional Manufacturer Narrative
The components subject of the reported event are being returned for evaluation.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the generator power control box was damaged.While onsite, the technician replaced the control box.The unit was tested, confirmed to be operating according to specifications, and returned to service.The generator power control box subject of the reported event was returned to steris for evaluation.Based on the evaluation completed, an exact root cause of the reported event could not be determined.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 600 STEAM STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20929417
• Report Number: 3005899764-2024-00074
• Device Sequence Number: 8314371
• Product Code: FLE
• UDI-Device Identifier: 00724995179632
• UDI-Public: (01)00724995179632(11)201027
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: AMSCO 600 STEAM STERILIZER
• Device Catalogue Number: EF1301142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• 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