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

Model Number N/A

Device Problem Failure to Power Up (1476)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

It was reported unit will not power on when plugged into wall.The event timing was not during surgery.No patient involvement or harm.During investigation, it was found that there were signs of burn, fire, char.No harm noted and no smoke was involved.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).The results of the investigation are as follows: review of the most recent repair record determined the power inlet module fuse ports were blistered with blown fuses.The power inlet module and the power module connectors were replaced and resolved the reported issue.A definitive root cause cannot be determined; the event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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
• 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: 15215043
• MDR Text Key: 304922056
• Report Number: 0001954182-2022-00076
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024466005
• UDI-Public: (01)00889024466005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172481
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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: 00514010200
• Device Lot Number: 0027572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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