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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE SYNERGY WASHER/DISINFECTOR

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STERIS CANADA ULC RELIANCE SYNERGY WASHER/DISINFECTOR Back to Search Results
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2023
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the reliance synergy washer/disinfector.The technician reviewed the cycle printout and was able to confirm that prior to the reported event the unit alarmed for a "motor overloads tripped".The technician discussed his evaluation of the unit with user facility personnel and stated that the unit was repairable however, in lieu of repairs the user facility decided to purchase a new steris amsco 5052 washer/disinfector.The reliance synergy washer/disinfector subject of the reported event is approximately 10 years old.The reliance synergy washer/disinfector subject of the reported event is being sent back to steris quality for further evaluation.A follow-up report will be submitted when additional information becomes available.
 
Event Description
The user facility reported that a "humming" noise was coming from their reliance synergy washer/disinfector following the start of a cycle.User facility personnel turned off the power to the unit and removed the instruments.The noise continued followed by a burning smell and smoke coming from the unit.In addition, user facility personnel observed small flames coming from the back side of the unit.The flames were extinguished by user facility personnel by utilizing a fire extinguisher.No report of injury.
 
Manufacturer Narrative
The reliance synergy washer/disinfector subject of the reported event was sent back to steris quality for evaluation.Visual inspection of the unit confirmed that the fire originated in the motor of the recirculation pump.Further inspection of the recirculation pump motor found that it was operating on both high and low speeds subsequently causing the observed "motor overloads tripped" alarm by user facility personnel.Through follow-up, it was confirmed that during the time of the reported event, user facility personnel acknowledged the "motor overloads tripped" alarm and continued to run the cycle which subsequently led to the reported fire.The operator manual states (pg.7-10), "alarm sounds, and display shows: alarm: motor overload tripped.Press alarm reply touch pad to silence alarm tone.2.Call steris.".
 
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Brand Name
RELIANCE SYNERGY WASHER/DISINFECTOR
Type of Device
WASHER/DISINFECTOR
Manufacturer (Section D)
STERIS CANADA ULC
490 boulevard armand-paris
quebec, G1C 8 A3
CA  G1C 8A3
Manufacturer (Section G)
STERIS CANADA ULC
490 boulevard armand-paris
quebec, G1C 8 A3
CA   G1C 8A3
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key16382839
MDR Text Key309633818
Report Number9680353-2023-00005
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/15/2023
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2023
Initial Date FDA Received02/15/2023
Supplement Dates Manufacturer Received01/18/2023
Supplement Dates FDA Received07/16/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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