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

Model Number V-PRO maX

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

The user facility stated that following the reported event, an employee went to retrieve the instruments from inside the v-pro max sterilizer and obtained a contact burn.The employee sought and received medical treatment.A steris service technician arrived onsite to inspect the unit.Due to the damage that the sterilizer sustained during the time of the reported event the unit could not be repaired and was removed from service.During the technicians inspection he observed charred fabric material laying next to the unit.The technician stated that the fabric material could have contributed to the start of the fire however, it is not conclusive if this was the source of the fire.Due to the damage the v-pro max sterilizer sustained; the user facility placed an order and purchased a new v-pro max sterilizer.No additional issues have been reported.

Event Description

The user facility reported that during a cycle the lower compartment of their v-pro max sterilizer caught on fire.User facility personnel were able to extinguish the fire with a fire extinguisher and unplug the unit.

• 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
• 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: 16383460
• MDR Text Key: 309633268
• Report Number: 3005899764-2023-00006
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: 00724995206987
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-PRO maX
• Device Catalogue Number: VP30002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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