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 Problems Thermal Decomposition of Device (1071); Melted (1385); Failure to Power Up (1476)

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that this unit will not turn on and the fuses melted into the power inlet module.There were signs of fire, burning, and charring as the fuse was melted in the power inlet module.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Investigation is completed.This is an initial final report submission.Review of the most recent repair record determined the unit would not turn on due to blown fuse in the power inlet module.The power inlet module was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 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: 15244559
• MDR Text Key: 298106820
• Report Number: 0001954182-2022-00079
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 44604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• 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