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

Catalog Number UE514010100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.Product evaluated by external contractor.

Event Description

It was reported that after surgery the unit had a burning smell and did not result in harm or delay.There was no smoke or spark.The cart did shut down with an over temp error.The new vacuum pump that was installed two days prior caused the burning smell.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information is available.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Upon receipt of additional information, it was determined that the device in question did not cause or contribute to the reported event.This file was submitted in error and should be voided.

• Brand Name: DUO FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9706108
• MDR Text Key: 198533814
• Report Number: 0001954182-2020-00009
• 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: 03/06/2020

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 Catalogue Number: UE514010100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1