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

Catalog Number 00514010200

Device Problems Device Emits Odor (1425); Intermittent Loss of Power (4016)

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

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.Evaluated by external contractor.

Event Description

It was reported that the unit overheated and shut down during a case.The event timing was during surgery.There was no harm or delay to the patient.There was no sparks, smoke or flame due to overheating.There was a slight burning smell from the vacuum pump.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.D4 - udi #: (b)(4).The previous repair record for intellicart system serial number (b)(6) 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 16 december 2019, (b)(4) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and found that the unit was tagged out with a note stating that the unit had overheated and shut down.He noted no overheat errors in the error logs, but did note a vacuum sensor 2 error and that the manifold housing on cylinder 2 was not seated properly and the set screw was creating a gap which was causing a vacuum leak.The technician reseated the manifold housing and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev.0.The root cause for the unit overheating and shutting down was due to an improperly sealed manifold housing.An improper seal would cause the vacuum pump to work harder to generate the negative pressure required for the unit to function, and this would cause the vacuum pump to overheat and shut down the device.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the manifold housing was reseated.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 (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• 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: 9582332
• MDR Text Key: 194601204
• Report Number: 0001954182-2020-00001
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 0041453
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1