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

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being investigated.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the unit was not working properly, level sensor was not reading correctly on either cylinder.The event timing was before surgery.Investigation indicated an issue with the vacuum pump.No adverse events were reported as a result of this malfunction.

Event Description

When the repair tech arrived on site, it was noted that this event was misreported.Additionally service technician identified an issue with vacuum pump.

Manufacturer Narrative

This event was recorded with zimmer biomet under (b)(4).Udi (b)(4).The product was evaluated by an external contractor.The previous repair record of intellicart system unit 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.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired by zimmer biomet surgical 5 times.The last repair was done for carbon filter issue and it is not related to the current repair.On 12 november 2018, it was reported from montefiore medical park that unit was not working properly.The service technician arrived at the site on 16 november 2018 and he was unable to duplicate the concern regarding level sensor, but additionally he noted that vacuum pump was not turning on and vacuum sensor errors 1 &2 in error log, then he confirmed that event was misreported.After that he replaced vacuum pump for the unit and confirmed that the unit was functioning as intended.The service technician then returned the unit back to service without any further concerns.The unit was tested, inspected, and repaired.Service work order dms-47744-f1g9c9 on 12 november 2018.The service technician confirmed that event was misreported for level sensor error, in addition to that he was unable to reproduce the reported event when the unit was inspected and tested on 16 november 2018.The root cause of vacuum issue was due to defective vacuum pump.If the air flow of the unit was disrupted the unit will then read that inadequate pressure is being generated and trigger a vacuum sensor error, vacuum pump will not turn on.Therefore, root cause of the reported event cannot be specifically determined with the provided information.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: 8141864
• MDR Text Key: 129757835
• Report Number: 0001526350-2018-01087
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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: 0023882
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1