MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT

Model Number	N/A
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been reported under (b)(4).Upon completion of investigation a final/supplemental report will be submitted.If any additional information is provided a supplemental report will be submitted.
Event or Problem Description
It was reported that outside of surgery, when the machine was plugged in it burned the fuses and the power cord from connection to machine.No adverse events were associated with this malfunction as no patient involvement was noted.Due diligence is in process and there is no additional information available at this time.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the power cord was burnt and the power inlet module fuses were blown (no melting/burning/charring of the power inlet module found).The power inlet module was replaced and resolved the reported issue.A definitive root cause cannot be determined.The event is confirmed.Review of the device history record identified no deviations or anomalies during manufacturing.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.
Event or Problem Description
It was reported that the fuse was blown on the power inlet module.Due diligence is complete and there is no additional information regarding the event.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Common Device Name: SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT
• 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: 16263933
• Report Number: 0001954182-2023-00013
• Device Sequence Number: 17186960
• Product Code: JCX
• UDI-Device Identifier: 00889024466005
• UDI-Public: (01)00889024466005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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 Model Number: N/A
• Device Catalogue Number: 00514010200
• Device Lot Number: 0040813
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown