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

Model Number N/A

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted 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 the unit started smoking during a case.No patient harm or serious injury has been reported at this time.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

This follow up report is being submitted to report additional information.

Event Description

It was reported that unit started smoking during a case.The device had a shorted connection from the monitor to the main control board.The event occurred after surgery.Based on feedback from the account.The technician discovered a shorted connection between the monitor and the main control board.There was no medical intervention.There was no harm/injury to the patient or operator.No other device was used to complete/finish the surgery.No delay in the surgical procedure.Surgical technique for the product was utilized.There was no patient involvement.

Event Description

The cart is full of dirty fluid and when tried to dock the screen wouldn¿t turn on.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).The product was evaluated by an external zimmer contractor.The previous repair report 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 report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 2 times, the previous repair being for request on evaluating the unit 23 feb 2018.The no problem found issue was not associated with the current repair service, so the previous repair was a non-related issue.On may 15, 2018, it was reported from (b)(6) hospital that this cart today at (b)(6) shorted out and started smoking during a case.The cart is full of dirty fluid and when tried to dock it the screen wouldn¿t turn on.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on may 17, 2018 and found that the cart power appeared to be fully functional but the display would not power on as the display cable had signs of shorting out to the board.The technician replaced the display (part#70056), display cable and control board (part#70064) 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.Service work order (b)(4) on may 15, 2018.The root cause of the reported event of screen wouldn't turn on was due to that the shorted display cord which damaged the control board and display.If the display cord is damaged , it would prevent the monitor from receiving electricity as intended to power on.Where as the reported event of the unit smoke during the use was due to shorted display cable on the unit.If the display cable is damaged due to short, it would produce smoke when tried to use.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the display, display cable and control board were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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
• MDR Report Key: 7538793
• MDR Text Key: 109115772
• Report Number: 0001954182-2018-00031
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

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 Model Number: N/A
• Device Catalogue Number: 00514010200
• Device Lot Number: 0023622
• Other Device ID Number: (01)00889024466005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/21/2018; 07/03/2018
• Supplement Dates FDA Received: 06/20/2018; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1