MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Mechanical Problem (1384)

Patient Problem Swelling (2091)

Event Date 09/02/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their washer's loading-side door automatically closed against the neck of a hospital staff employee.No report of procedural delays or cancellations.Employee sought medical treatment and was given ibuprofen.Employee returned to work and later took one day off to see a physician regarding swelling.

Manufacturer Narrative

A steris field service technician arrived onsite and inspected the door's operation, obstruction readings, and safety measures.The technician confirmed the unit was operating properly.During the inspection of the unit the user facility reported to the technician that the employee subject of the event powered on the unit using the connect/disconnect switch on the wall but left the unit's main rocker switch in the "off/standby" position as opposed to the "power" position.The employee was cleaning the washer chamber at the time of the reported event.The door began to shut and retracted against the employee's neck.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

The reliance 444 maintenance manual states, "important: power-off/standby switch does not turn off electrical power to the unit." by putting the washer in standby position, "the operator has one minute to decide whether to cancel or not cancel the standby cycle (to cancel: reposition the power off/standby rocker switch to power position).After one minute, [if] the [main rocker switch] stays in the off/standby position [and] the door is not closed, [then] the control displays a message to close the door." the employee subject of the reported event failed to shut the door when prompted prior to the beginning of the standby cycle.Steris has offered the user facility in-service training which will be scheduled during (b)(4).

• Brand Name: RELIANCE 444 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4133153
• MDR Text Key: 4925643
• Report Number: 9680353-2014-00081
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2015
• 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 Number: 1
• Patient Outcome(s): Other