MAUDE Adverse Event Report: STERIS CORPORATION REVITAL-OX RESERT HIGH LEVEL DISINFECTANT; STERILANT

Model Number	4455AW
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a container of revital-ox resert high level disinfectant caught fire as it was placed on a warming mat.The fire was extinguished with a fire extinguisher.No report of injury.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was determined that the customer did not follow the proper safe storage conditions for the disinfectant as stated in the safety data sheets resulting in the reported event.The revital-ox resert high level disinfectant safety data sheet states, "7.2 conditions for safe storage, including any incompatibilities: keep only in original container.Keep container closed when not in use.Store in a dry, cool and well-ventilated place.Keep away from sources of heat (e.G.Hot surfaces), sparks and open flames.Keep out of direct sunlight." a 3-year complaint review indicates this to be an isolated event.Steris counseled user facility personnel on the proper use of the revital-ox resert high level disinfectant, specifically ensuring to keep containers away from sources of heat no additional issues have been reported.

• Brand Name: REVITAL-OX RESERT HIGH LEVEL DISINFECTANT
• Common Device Name: STERILANT
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15253146
• Report Number: 1937531-2022-00002
• Device Sequence Number: 6390133
• Product Code: MED
• UDI-Device Identifier: 00724995095017
• UDI-Public: 00724995095017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 4455AW
• Device Catalogue Number: 4455AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown