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 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that during cleaning the coupler had wires exposed.No adverse events were reported as a result of this malfunction.

Event Description

It was reported that during cleaning the coupler had wires exposed.Possibly the grommet has pulled away from the handle and did not result in harm or delay.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Reported event: on 26 november 2019, it was reported from (b)(6) medical center that an evac unit¿s coupler wires were exposed.Dhr and repair history review: the previous repair report for intellicart evacuation unit serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Device evaluations results/investigation findings: on 26 november 2019, it was reported from (b)(6) medical center that an evac unit¿s coupler wires were exposed.On 26 november 2019, (b)(6) construction was contacted about the evac and dispatched a service technician to be at the site.The technician arrived at the site and confirmed the issue.He found that the boot between the coupler and the hoses had become unseated, allowing the hoses and cables to be exposed.He reseated the boot.During testing he found one of the connectors on the main control board was unplugged, so he plugged it back in and then verified proper functions before returning the evac to service.Per crm, a repair checklist was not required.Probable cause/root cause: the root cause of the unit¿s coupler having exposed wires was due to the coupler boot becoming unseated.The boot is a sleeve that covers the bottom of the coupler handle to the hose that leads the coupler to the main body of the evac.The boot coming partially off would result in the wires that lead the hoses to the handle being exposed to the open.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended for any adverse trends that may require additional actions.

• 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: 9385849
• MDR Text Key: 194610525
• Report Number: 0001954182-2019-00077
• 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
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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: 0028442
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1