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

Catalog Number UE514010200

Device Problem Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that one cart has a burning oil smell when turned on and while being used.The event occurred before surgery.No harm or delay occurred.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9758721
• MDR Text Key: 199702808
• Report Number: 0001954182-2020-00012
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1