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

Catalog Number 00514010900

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation and evaluation of the device is in process.Once the investigation is completed, a supplemental report will be filed.

Event Description

It has been reported that the evac had exposed wires on the coupler.The event timing was during cleaning.There was 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).D4 udi: (b)(4).This medwatch is being filed to relay additional information.Product evaluation product review of the intellicart evac sn (b)(6) by a zimmer biomet certified service repair technician 17 april 2020 revealed that the coupler boot had come off exposing the wires.The technician could not reproduce the burning smell, but replaced the coupler.Product repair of the device was performed by a zimmer biomet certified service repair technician on 17 april 2020 which included replacement of the following: coupler the device, serial number (b)(6), was then tested and functioned properly.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

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
• MDR Report Key: 9957159
• MDR Text Key: 199701567
• Report Number: 0001954182-2020-00019
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010900
• Device Lot Number: 0027585
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1