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

Catalog Number UE514010100

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.

Event Description

It was reported that the unit was having a counting issue, it wasn't working on either side.There was no harm or delay reported.The event timing was during cleaning.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Following sections were updated or corrected : b4, b5, d4, d9, g6, g3, h1, h2, h3, h4, h6, h10.Review of the most recent repair record identified no repairs related to the reported event.A definitive root cause cannot be determined.The event cannot be 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.

Event Description

There is no additional event information available.

• Brand Name: DUO FLUID CART
• 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: 15598674
• MDR Text Key: 302360835
• Report Number: 0001954182-2022-00094
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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