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

Model Number 7052HP

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that their amsco 7052 hp washer/disinfector caught fire.The fire was extinguished.No report of injury.

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
• Type of Device: 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
• MDR Text Key: 317222553
• Report Number: 9680353-2023-00017
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995176587
• UDI-Public: 00724995176587
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 7052HP
• Device Catalogue Number: FH18042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1