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

Catalog Number 00514010200

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been evaluated by an external contractor and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.Device evaluated by manufacturer? evaluated by external contractor.

Event Description

It was reported that the cart was failing the electrical test.It was causing an alarm in the or room.The customer said the power cord tested fine but the cart did not.It was giving off a smell as though the cart got hot.The event timing was during surgery; no harm and no delay reported.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 been previously repaired 3 times, the previous repair being for a drain issue on jan 22, 2019.The carbon filter is not associated with the current repair.Thus, this repair was a non-related issue.On may 13, 2019 it was reported from (b)(6) hospital that the cart was failing the electrical test.On may 14, 2019 a zimmer biomet authorized service technician was contacted and dispatched to be at the site.Upon investigation, he confirmed the reported event, finding that the reported event was caused by fluid being pulled into the smoke evac and the disposable cartridge.A warranty replacement smoke evac was ordered on may 14, 2019.On may 16, 2019 the new smoke was delivered and installed.All functions were tested and the cart and unit were returned to service.Per crm, current repair checklist not required.Service work order (b)(4) on may 13, 2019.The root cause of the reported event was due to a damaged smoke evac.The smoke evac is used in conjunction with the cart to remove smoke from a surgical setting and fluid accidentally being pulled into the smoke evac can cause damage resulting in smoke evac malfunction.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the smoke evac was replaced.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 available.

• 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: 8675827
• MDR Text Key: 147234587
• Report Number: 0001954182-2019-00038
• 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
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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: 0025574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1