MAUDE Adverse Event Report: STERIS CANADA ULC STERIS INSTRUMENT DECONTAMINATOR; DISINFECTOR, MEDICAL DEVICES

Model Number VISION SC

Device Problem Fire (1245)

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

Event Date 08/24/2022

Event Type  Injury  

Event Description

The fluorescent light bulb cord caught fire.The light bulb sits inside the instrument washer and the wires attach to a ballast on top of the instrument washer.The unit did not trip any fuses or circuit breakers.There was no staff or patient injury.The flames self extinguished when the power was turned off to the unit.The vendor does have a led replacement kit for the fluorescent bulb but it is not a required or advertised part.There is also no scheduled maintenance on the seal that provides moisture from reaching the bulb.Fda safety report id# (b)(4).

• Brand Name: STERIS INSTRUMENT DECONTAMINATOR
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERIS CANADA ULC; mentor OH
• MDR Report Key: 15417947
• MDR Text Key: 299861851
• Report Number: MW5112000
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VISION SC
• Device Catalogue Number: VISION SC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1