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

Model Number N/A

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that outside of surgery the device is not working as the screen turns black.Upon evaluation it was noted that the power inlet module was burnt.No harm or delay were reported as no patient involvement was noted.No adverse event was reported as it relates to the event.Due diligence is complete and no additional information is available.

Manufacturer Narrative

This incident has been recorded under (b)(4).Review of the most recent repair record determined the unit was confirmed to not power on.The power inlet module was burnt.The power inlet module was replaced and that resolved the reported issue.The root cause of the reported issue is attributed to the time the high flow valve is left open, is too short during the pump start up sequence.The event is confirmed.If any further information is found which would change or alter any conclusions or information a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15588266
• MDR Text Key: 304462144
• Report Number: 0001954182-2022-00093
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024501638
• UDI-Public: (01)00889024501638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 00514010400
• Device Lot Number: 44338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1