MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7052 HP WASHER/DISINFECTOR

Model Number	7052HP
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their amsco 7052 hp washer/disinfector caught fire.The fire was extinguished.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite and was informed that the facility's biomed department inspected the unit prior to his arrival.The steris technician learned from the biomed department that an employee reported that the unit alarmed "sump over temperature switch tripped (critical)".The power to the unit was then shut down.The biomed department then restored power to the unit, and it alarmed "rinse reservoir temperature probe defective" and "power failure during cycle".Following the reported alarms, the unit caught fire within the rinse reservoir and the fire was extinguished.The amsco 7052 hp washer/disinfector operator manual states (188), "7.62 alarm# 12 sump over temperature switch tripped (critical), 1.Press silence buzzer on touch screen to stop alarm buzzer.2.Press ack on touch screen to acknowledge alarm.3.Press abort on touch screen to abort cycle.4.Wait for temperature to cool down prior to opening door and removing load.5.Contact steris." the steris service technician inspected the unit and confirmed that the fire originated in the rinse reservoir.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO 7052 HP WASHER/DISINFECTOR
• Common Device Name: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17134473
• Report Number: 9680353-2023-00017
• Device Sequence Number: 20445197
• Product Code: MEC
• UDI-Device Identifier: 00724995176587
• UDI-Public: 00724995176587
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/15/2023

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: 7052HP
• Device Catalogue Number: FH18042
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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