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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 the flow sensor wires were damaged.The flow sensor was replaced and resolved the reported issue.Root cause: the flow sensor records whether or not bleach and enzyme are being dispensed correctly during cleaning cycles.A flow sensor malfunction can occur before, during, or after regular cart usage; the circuit board on the flow sensor can become overcharged or fail by other means, and cause electrical malfunction, causing incorrect chemical flow readings.This error can also cause the unit to erroneously read and report that the bleach and enzyme containers are empty.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each flow sensor failure is generally not possible.
Event or Problem Description
It was reported that the evac was giving bleach and enzyme empty errors when not empty.Flow sensor not functioning during cleaning.There was no harm or delay.Investigation showed damaged wires and photo showed they were exposed.No adverse event was 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: 11752754
• Report Number: 0001954182-2021-00022
• Device Sequence Number: 19894648
• Product Code: JCX
• UDI-Device Identifier: 00889024466012
• UDI-Public: (01)00889024466012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 0040726
• 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: 04/29/2021
• Initial Report FDA Received Date: 04/30/2021
• 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