Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER Back to Search Results
Device Problem Fire (1245)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2020
Event Type  malfunction  
Manufacturer Narrative
A steris service technician performed an inspection of the reliance vision single chamber washer and found the unit to not be operational.A replacement unit will be installed.The unit subject of this event will be returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported that their reliance vision single chamber washer caught fire.The department was evacuated, and the fire department was dispatched.The fire department extinguished the flames.No report of injury.
 
Manufacturer Narrative
The unit subject of the event was returned to steris for evaluation and it was determined that the components were too damaged to determine a root cause of the reported event.The unit was installed in 2011 making it approximately 9 years old.The customer was provided with a replacement washer.No additional issues have been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RELIANCE VISION SINGLE CHAMBER WASHER
Type of Device
WASHER
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, GIC 8 A3
CA  GIC 8A3
MDR Report Key9991096
MDR Text Key188995844
Report Number9680353-2020-00019
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/23/2020
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
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/04/2020
Initial Date FDA Received04/23/2020
Supplement Dates Manufacturer Received04/04/2020
Supplement Dates FDA Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-