MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).The product will be evaluated by an external contractor.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that unit was leaking from the bottom.Additional information clarified that the event occurred during surgery.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This follow-up report is being submitted to relay additional information.On 10 january 2018, (b)(4) inc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that the unit was leaking, and noted that the unit was not connecting to the evac station properly.The technician replaced the receiver drained the condensation tube, and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.The root cause for the unit leaking form the bottom was due to fluid in the condensation tube.The condensation tube is to allow the steam from the hot water in the cart to escape during processing, and this steam can condense and collect in the condensation tube.This can give the appearance of a leak.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the condensation tube was drained.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 7200829
• MDR Text Key: 97878339
• Report Number: 0001954182-2018-00006
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00514010200
• Device Lot Number: 0023808
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1