MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 00514010200

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for intellicart system 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 record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On july 29, 2019 it was reported from (b)(6) that the unit had smells like something was burning.On june 29, 2019 a zimmer biomet authorized service technician was contacted and dispatched to be at the site.Upon investigation, the technician troubleshot and found that the vacuum pump won't come on, and the unit gives vacuum sensor errors.Fuses were checked and were good.He replaced the vacuum pump (part# 70098, lot code 0040609).The device was tested, inspected, and repaired.Service work order (b)(4) on july 29, 2019.While the service technician was able to return the device to service after replacing the vacuum pump to address the vacuum sensor error he discovered during his investigation, this vacuum pump resolution is unrelated to the reported event of there being a burning-like smell.A specific root cause of the reported event can therefore neither be determined nor confirmed as we cannot say for sure if there is a connection between the discovered vacuum sensor error and the reported burning smell.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that a duo fluid cart had smells like something was burning.No adverse events were reported as a result of this malfunction.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• 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: 8873995
• MDR Text Key: 162127154
• Report Number: 0001954182-2019-00048
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2019

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 Catalogue Number: 00514010200
• Device Lot Number: 0026114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1