MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Fluid/Blood Leak (1250); Smoking (1585)

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

Event Date 08/05/2021

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 cord had fluid on it and started to smoke.Fluid dripped down the back of the cart to power inlet module.Module melted and the power cord burned.The event timing was during cleaning.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.

Event Description

No additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d4, d8, g3, g6, h1, h2, h3, h6, h8, h10 -review of the most recent repair record determined that the power inlet module and wye power cord were damaged.The power inlet module and wye power cord were replaced and resolved the reported issue.-device is used for treatment.-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.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 12303339
• MDR Text Key: 265888679
• Report Number: 0001526350-2021-00898
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K190789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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: 00514010400
• Device Lot Number: 0041458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1