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

Catalog Number 00514010200

Device Problems Image Display Error/Artifact (1304); Device Emits Odor (1425)

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

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the duo fluid cart had a burning smell and was showing an error on the display.The event timing was unknown but no adverse events were reported as a result of this malfunction.

Event Description

It was reported that the unit had a burning smell and was showing an error on the display.The event timing was during cleaning.During technician inspection, no odor, nor any signs of the unit leading to produce an odor could be replicated.There was no harm or injury involved.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).The device history record (dhr) for intellicart system serial number (b)(4) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.On 17 june 2019, it was reported from (b)(6) medical center that the unit had a burning smell and was showing an error on the display.On 17 june 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On 18 june 2019, the technician arrived at the site but could not find any odor or signs that would lead to an odor.The technician could also not find any errors on the unit.The technician verified that the unit was functioning as intended then returned the unit to service without further incident.Service work order (b)(4) on 17 june 2019.The reported event was not confirmed during inspection of the device; therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information was recieved.

• 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: 8780507
• MDR Text Key: 150706026
• Report Number: 0001954182-2019-00045
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010200
• Device Lot Number: 0026600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1