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

Model Number N/A

Device Problems Difficult to Flush (1251); Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

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

It was reported that the unit is not draining and the wires on the coupler are exposed.The event did not occur during surgery.No patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d4, g2, g3, g6, h2, h3, h4, h6, h10.Review of the most recent repair record determined the unit was not draining and the wires on the coupler were exposed.The evac coupler was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.

Event Description

No additional event information available.

• Brand Name: EVAC STATION
• Type of Device: 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: 15519513
• MDR Text Key: 301122966
• Report Number: 0001954182-2022-00090
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024466012
• UDI-Public: (01)00889024466012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00514010900
• Device Lot Number: 0029943
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1