MAUDE Adverse Event Report: STERIS CORPORATION V PRO; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Device Problems Fire (1245); Smoking (1585)

Patient Problem Chemical Exposure (2570)

Event Date 05/16/2019

Event Type  malfunction  

Event Description

Fire in reprocessing area caused by v pro max sterilizer catching on fire while in use.Fire suppression system activated which put out the fire but also caused flooding in the area.Pediatric floor evacuated for brief time.Staff sent to emergency department from hydrogen gas exposure and smoke inhalation.The product representative had been in the day of the fire for maintenance on the sterilizer.

• Brand Name: V PRO
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone dr; mentor OH 44060
• MDR Report Key: 8832515
• MDR Text Key: 152378132
• Report Number: 8832515
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other