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

Model Number	V-PRO maX
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer and found it to be not operational.The damage was contained within the footprint of the unit.Prior to the reported event, the unit had alarmed "chamber overtemp".The user facility was provided with a loaner unit.Steris has requested the unit subject of the event be returned for evaluation; we are pending release of the unit by the customer.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their v-pro max sterilizer caught fire.No report of injury.
Additional Manufacturer Narrative
The v-pro max sterilizer subject of the event was returned to steris for evaluation.The evaluation found that the tee underneath the reservoir was leaking sterilant.The sterilant leaked onto the sterilizer's components resulting in the reported event.The tee should be replaced annually in accordance with the v-pro max sterilizer preventive maintenance checklist.The unit was installed in 2018 and is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.No additional issues have been reported.

• Brand Name: V-PRO MAX STERILIZER
• Common Device Name: 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: 12369796
• Report Number: 3005899764-2021-00047
• Device Sequence Number: 4496981
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: 00724995206987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 07/27/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 11/12/2021; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown