MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an over pressure alarm occurred on their amsco 400 sterilizer.Following the alarm, the user facility shut off the electrical utilities for the sterilizer but inadvertently left the separate electrical utilities to the sterilizer's steam generator powered on, subsequently causing the unit to overheat.No injuries were reported.
Additional Manufacturer Narrative
Investigation for the reported event is still in process.A follow-up report will be submitted when additional information become available.
Additional Manufacturer Narrative
A steris service technician arrived onsite and found the circuit breaker to the sterilizer's steam generator to be on and the power to the sterilizer to be off.As the circuit breaker power to the sterilizer's steam generator was on, this allowed power supply to the heater elements causing remaining water within the generator to boil off.As the power to the sterilizer was shut off no water was being added to the generator subsequently causing the components to overheat.The steris service technician counseled user facility personnel on the importance of shutting off power to the steam generator when the power to the sterilizer is turned off.A complaint review considers this to be an isolated event.The user facility purchased a new sterilizer and no additional issues have been reported.

• Brand Name: AMSCO 400 STERILIZER
• Common Device Name: 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 ; 4403927453
• MDR Report Key: 14878872
• Report Number: 3005899764-2022-00028
• Device Sequence Number: 11260109
• Product Code: FLE
• UDI-Device Identifier: 00724995209230
• UDI-Public: 00724995209230
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR0101110111
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2017
• 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