MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO CART WITH SMOKE EVAC; SEE H10

Model Number N/A

Device Problem Output Problem (3005)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Common device name: apparatus, suction, ward use, portable, ac-powered.Pma/510k number: k081047; k123188; k133786.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

Ultra duo high fluid cart was not reading fluid level properly on either side.The event timing is unknown.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for ultra duo flex fluid cart serial number 132957 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 2 times.The last repair for this cart was done for valve pack issue and it is not related to the current repair.On 14 august 2018, it was reported from university of iowa that unit was not reading fluid level properly on either side.The service technician from day mechanical systems arrived at the site on 16 august 2018, evaluated the unit for reported event and confirmed that the fluid levels on both cylinder #1 and #2 were not reading correctly.After that service technician replaced level sensors on both the cylinders and confirmed that 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.The root cause for the unit issuing level sensor error was due to a malfunctioning level sensor.The level sensor is responsible for measuring the fluid levels in the cart, and a malfunctioning level sensor would cause the reported event.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensor was 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: ULTRAFLEX DUO CART WITH SMOKE EVAC
• Type of Device: SEE H10
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 7875477
• MDR Text Key: 120249934
• Report Number: 0001954182-2018-00061
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PSEE H10
• 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: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• 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: ULDU500SE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1