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

Catalog Number	00514010200
Medical Device Problem Codes	Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the power inlet module failed and there was a burnt smell/odor.Another cart was brought in to complete the surgery with no delay in procedure.The surgery was completed then the fire department came in.The patient was not in the operating room when the fire department entered.No patient involvement.No harm reported.Diligence is complete.Upon device evaluation it was stated that - the failure was so catastrophic the or was filled with smoke.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the power inlet module was confirmed to be nonfunctional; however, the repair was not completed because the unit was disposed of on site before the unit could be returned for further evaluation.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a component failure.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22115017
• Report Number: 0001954182-2025-00011
• Device Sequence Number: 7175685
• Product Code: JCX
• UDI-Device Identifier: 00889024466005
• UDI-Public: (01)00889024466005
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00514010200
• Device Lot Number: 0029265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown