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 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the v-pro max sterilizer; however, the user facility did not allow the technician to perform a full investigation as they wanted to conduct their own investigation first.At this time a root cause is unable to be determined as steris does not have access to the v-pro max sterilizer.A follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported that their v-pro max sterilizer had caught fire.The department was evacuated, and the fire department was dispatched.The fire department extinguished the flames.Procedure cancellations were reported as the department shut down.User facility personnel were sent to the emergency room for evaluation.

Manufacturer Narrative

Upon receipt of user facility medwatch mw report # 2300170000-2019-8012 on 8/1/2019, we reviewed our service history and confirmed the event described in medwatch mw report # 2300170000-2019-8012 is the same event which was reported in mdr 3005899764-2019-00060.A steris service technician arrived onsite following the reported event to inspect the v-pro max sterilizer; however, the user facility did not allow the technician to perform a full investigation as they wanted to conduct their own investigation first.This investigation is still ongoing.A follow-up mdr will be submitted should additional information become available.

Manufacturer Narrative

The user facility hired a third-party to perform a destructive fire inspection of the v-pro max sterilizer subject of the event.Steris representatives as well as a fire expect hired by steris attended the inspection.The fire expert reported that the fire started in the v-pro max sterilizer and it was not an electrical fire.Additionally, the fire expert reported there was a charred fabric material at the floor of the unit; however, it is not conclusive if this was the source of the fire.At this time, a specific root cause could not be determined.No additional issues have been reported.

• 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, 67190 ; MX 67190
• MDR Report Key: 8693477
• MDR Text Key: 148155368
• Report Number: 3005899764-2019-00060
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1