MAUDE Adverse Event Report: DORNOCH MEDICAL SAFETY STATION PLUS

Catalog Number TP-SS200

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

It was initially reported that smoke was coming from the back of the safety station plus and the unit displayed error code 270106.Additional clinical follow-up identified that the unit began smoking at the start of the cleaning cycle.The hot water master valve was getting hot and smoking while there were visible burning wires and charred plastic.The customer shut off the unit completely and the sterile processing department used an alternative method to process the waste.It was confirmed that there was no harm involved.

Manufacturer Narrative

The safety station plus was installed on (b)(4) 2008 and was last repaired on (b)(4) 2012 for a non-related issue.The device was not made available for eval or repair by zimmer surgical.The customer canceled service/repair on this device as they planned to order a new device.The customer's reported event could not be confirmed and a cause could not be determined.Please note that the device is overdue for preventative maintenance.Failure to follow the preventative maintenance schedule could lead to failures caused by normal use or wear.

• Brand Name: SAFETY STATION PLUS
• Type of Device: SAFETY STATION PLUS
• Manufacturer (Section D): DORNOCH MEDICAL; 200 nw pkwy rd; riverside MO 64150
• Manufacturer Contact: kathleen smith ; 200 nw pkwy rd; riverside, MO 64150 ; 3303649447
• MDR Report Key: 4814533
• MDR Text Key: 5834892
• Report Number: 1954182-2015-00001
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TP-SS200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1