MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 16" CENTURY STERILIZER

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 16" century sterilizer.While onsite, the user facility provided the technician with their cycle tapes.The technician reviewed the tapes and did not identify a cycle tape that aligned with the alarm subject of the reported event.The unit will alarm if the chamber does not reach the set temperature within the allotted time.The alarm indicates that the facility's steam supply is not providing sufficient steam to reach the set temperature.Additionally, the technicians spoke with the user facility's biomed department who stated that after reported event they had to "reset" the unit and returned the sterilizer to service.The technician performed an inspection and found no issue with the function or operation of the sterilizer.No repairs were required.No additional issues have been reported.

Event Description

The user facility reported via user facility medwatch report number (b)(4) that their 16" century sterilizer did not reach the proper temperature to continue the cycle.

• Brand Name: 16" CENTURY 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 ; 3927453
• MDR Report Key: 9787986
• MDR Text Key: 184922042
• Report Number: 3005899764-2020-00009
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• 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