MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER

Device Problem Fire (1245)

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

Event Date 02/10/2019

Event Type  malfunction  

Manufacturer Narrative

On monday, user facility personnel arrived onsite and noted a "burning smell" throughout the room.Facility personnel inspected the v-pro max sterilizer and found evidence of blackened wires and components around the insulation of the unit.A steris service technician arrived onsite to inspect the sterilizer and found the root cause of the reported event to be a loose fitting on the sv5 valve.As the fitting was loose, this allowed sterilant to leak from the valve onto the wires and components below causing the electrical wires to short and the reported event to occur.The v-pro max sterilizer was manufactured in 2015 and is not under a steris service agreement for maintenance activities.Facility personnel are responsible for all maintenance activities.The reported event can be attributed to user error as facility personnel should have ensured all fittings are properly tightened following all service or maintenance activities prior to placing the unit back in service.While onsite, the technician counseled facility personnel on the importance of ensuring that all fittings are properly tightened following all service or maintenance activities.The unit has been removed from service and no additional issues have been reported.

Event Description

The user facility reported that their v-pro max sterilizer caught fire over the weekend.There were no injuries associated with the subject event and the flames subsided on their own.

• Brand Name: V-PRO MAX STERILIZER
• 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 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8400428
• MDR Text Key: 138409306
• Report Number: 3005899764-2019-00021
• Device Sequence Number: 1
• Product Code: MLR
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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: 02/11/2019
• 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