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

Model Number N/A

Device Problems Decrease in Suction (1146); Smoking (1585)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the unit had low suction and the inline filters and hepa filter were clogged due to smoke intake.The inline filters and hepa filter 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 device is only assigned a unique serial number, an additional review could not be performed.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.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 unit has weak suction after surgery.Upon tech inspection, both in-line filters and hepa filter were dirty from the account pulling smoke into the cart.No adverse events were reported as a result of this malfunction.

• Brand Name: DUO FLUID CART WITH POWER IV, 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: 12318138
• MDR Text Key: 266384570
• Report Number: 0001954182-2021-00047
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024501645
• UDI-Public: (01)00889024501645
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

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: UE514010300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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