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

Model Number	7052HP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated that the amsco 7052hp washer/disinfector alarmed for a "load door obstruction" when the subject employee was loading a rack into the unit's chamber.The employee proceeded to silence the alarm, as no obstruction was observed.The employee commanded the chamber door to close however, the door would not lower, and the load door obstruction alarm continued to be displayed.The employee silenced the load door obstruction alarm multiple times and proceeded to load the rack when the reported event occurred.The amsco 7052hp washer/disinfector operator manual states, (section 7.76) "alarm# 26 load door obstructed: press silence buzzer on touch screen to stop alarm buzzer.Press ack on touch screen to acknowledge alarm.Clear door path from obstruction and try to close door again.If situation reoccurs, contact steris." a steris service technician arrived onsite following the reported event and found no issues with the function or operation of the amsco 7052hp washer/disinfector.In addition, the technician confirmed no issues with the function or operation of the load door or door obstruction bar.Based on the information provided and the technician's inspection, it is likely that there was an obstruction at the time the unit was alarming that was not observed by the user facility employee.The technician counseled user facility personnel on the proper use and operation for the amsco 7052hp washer/disinfector and the importance of following proper procedure for acknowledging alarms.The technician returned the unit to service; no additional issues have been reported.
Event or Problem Description
The user facility reported that while an employee was attempting to load a rack into their amsco 7052hp washer/disinfector while the unit was alarming, the door lowered subsequently contacting an employee's hand and causing a bruise.Medical treatment was sought and administered (patch).

• Brand Name: AMSCO
• Common Device Name: AMSCO 7052HP WASHER/DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20691317
• Report Number: 9680353-2024-00037
• Device Sequence Number: 8701248
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: (01)00724995176570(11)230308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7052HP
• Device Catalogue Number: FH18072
• 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: 10/17/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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