MAUDE Adverse Event Report: DORNOCH EVAC STATION; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number	N/A
Medical Device Problem Codes	Image Display Error/Artifact (1304); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the unit was getting water valve and comm errors due to burnt contacts on the nose board and that the leak detector had failed.The leak detector and coupler nose board were replaced and the master and hot water valves were rebuilt and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
Event or Problem Description
It was reported the carts intermittently will not connect to this unit and the unit is issuing water valve errors.The event timing was during cleaning.There was no harm to the patient.Investigation found the coupler had burnt contacts.There was no adverse event reported as a result of this malfunction.

• Brand Name: EVAC STATION
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 12008656
• Report Number: 0001954182-2021-00038
• Device Sequence Number: 14529515
• Product Code: JCX
• UDI-Device Identifier: 00889024466012
• UDI-Public: (01)00889024466012
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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: 00514010900
• Device Lot Number: 0029370
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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