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

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of the device is completed, a follow-up/final report will be submitted.

Event Description

It was reported that during cleaning, this device was discovered to have a torn boot and exposed wires.There was no patient involvement.No adverse events were reported as result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On 31 january 2020, it was reported from (b)(6) hospital that unit had a torn boot on the coupler with the wires exposed.On 31 january 2020, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On 31 january 2020, the technician arrived at the site and confirmed that there was a tear in the hose sheath.The technician replaced the coupler (part number 70027 and lot code number 0041188) and then verified that the evac was functioning as intended.The technician then returned the evac to service without further incident.The device was tested, inspected, and repaired.The reported event of the unit having a torn boot (tear in the hose sheath) on the coupler, resulting in exposed wires was confirmed by the technician.With the provided information, it is not known why this event happen so the root cause of the torn boot cannot be determined.The function of the boot and hose sheath is to act as a barrier around electrical cables or wires, protecting both user and electrical components.A tear in the coupler boot or hose sheath could result in exposed wire, potentially putting the user and electrical components at risk.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the coupler was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.H3 other text : product evaluated by external contractor.

Event Description

There is no additional information.

• 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: 9677614
• MDR Text Key: 194601796
• Report Number: 0001954182-2020-00006
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1