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

Model Number N/A

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow-up/final report will be submitted.

Event Description

During installation of the device, it was reported that there was a burning smell.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 no: (b)(4).The device history record (dhr) for intellicart system serial number (b)(4) was reviewed and 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.On 08 november 2019, a zimmer biomet sales rep requested that the cart be exchanged due to the complaint; the cart was not noted to be evaluated prior to the exchange request.An exchange order was subsequently written and submitted.A new cart (serial number (b)(4)) was shipped to the account and arrived on 12 november 2019.A zimmer biomet authorized service technician was dispatched to the account to complete the exchange, and confirmed the exchange was completed with the new unit in service without issue on 14 november 2019.The old cart was shipped back to riverside and arrived on 20 november 2019.Crm notes that the cart was exchanged by request of the rsm and sales rep; the odor concern was never confirmed.The unit will be refurbished with new serial number (b)(4); no additional information is available at this time.Because the reported event was never confirmed as a technician did not evaluate the unit for the odor concern and the unit was exchanged simply by request, it is not known what caused the reported odor issue.Therefore, a specific root cause cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action at this time, as this complaint is determined to not be a new confirmed quality or manufacturing issue.This complaint will be tracked and trended for any adverse trends that may require additional actions.

Event Description

No additional event information.

• 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: 9314932
• MDR Text Key: 194601231
• Report Number: 0001954182-2019-00074
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 0041617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1