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

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician inspected the sterilizer and found that the ck4 valve was not operating properly.As the ck4 valve was not functioning properly this allowed water to back up in the sterilizer's chamber overnight.When the employee opened the door the next morning, steam emitted from the sterilizer subsequently causing the reported event to occur.The operator manual states (1-2), "steam may be released from the chamber when door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." the steris service technician counseled user facility personnel on the proper use and operation for the amsco 400 sterilizer.The technician rebuilt the ck4 valve, tested the sterilizer and confirmed the unit to be operating properly.The sterilizer was returned to service and no additional issues have been reported.

Event Description

The user facility reported that steam emitted from their amsco 400 sterilizer after an employee opened the door.The steam contacted the employee's face and neck.It is unknown if the employee sought or received medical treatment.

• Brand Name: AMSCO 400 STERILIZER
• Type of Device: 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: 16028691
• MDR Text Key: 308465386
• Report Number: 3005899764-2022-00068
• Device Sequence Number: 1
• Product Code: FLE
• 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
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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