MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. REMANUFACTURED STERILIZER MODEL 2038

Device Problem Device Emits Odor (1425)

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

Event Date 03/26/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their remanufactured sterilizer model 2038 was emitting a burning smell.Evacuations were required.

Manufacturer Narrative

The investigation of this event is currently in process.A follow up report will be submitted when additional information becomes available.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified a malfunction of the contactor.The technician replaced the heater elements and contactor.As a proactive measure, the technician replaced the safety valve, tested the unit, and confirmed it to be operating according to specification."service required: (bimonthly inspection).Clean heating element and boiler chamber." if the user facility does not properly clean the heating element and the unit is not regularly maintained, it is possible the contactor may stick shut.The unit was installed on (b)(4) 2002 and is not under steris contract agreement for maintenance.

• Brand Name: REMANUFACTURED STERILIZER MODEL 2038
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4722483
• MDR Text Key: 5745018
• Report Number: 3005899764-2015-00029
• 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,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• 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: 03/26/2015
• 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