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

Model Number N/A

Device Problem Sparking (2595)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the cart would not run on and the power inlet module was bad and has melted, both fuses were also blown and the power cord was damaged.The power cord and inlet module were replaced and resolved the reported issue.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item.However, as the lot number is unknown, an additional review could not be performed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

It was reported the cart is not powering on during cleaning.The power inlet module melted and the head of the power cord that inserts into the power inlet module was charred from the event.There were no frayed or exposed wires.No adverse events were reported as a result of this event.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR - REFURBISHED
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11838047
• MDR Text Key: 257541069
• Report Number: 0001954182-2021-00025
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024466029
• UDI-Public: (01)00889024466029
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• 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: UE514010200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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