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

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the coupler nose board was charred.The coupler nose board was replaced, and resolved the reported issue.Review of the previous repair record identified that the unit would not connect to carts and required the coupler be replaced, which is related to the reported event.The device was tested, and found to be functioning to specification prior to release to the customer.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that ted, biomed at the account said the unit was not communicating with the carts during cleaning.No other information was provided.Investigation showed charring on the coupler.No adverse event was reported as result of this malfunction.

• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10867372
• MDR Text Key: 218215985
• Report Number: 0001954182-2020-00044
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2020

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: ULEV100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• 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