MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVAC AND POWER IV; SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT

Model Number N/A

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Other: device was inspected and repaired on-site by a third party.Upon receipt of additional information, the product return and the investigation is complete, a follow up/final report will be submitted.Explanation provided.

Event Description

It was reported that the unit was giving a burning smell.The event occurred prior to surgery.There was no patient involvement, delay in treatment or adverse events reported as a result of this incident.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).On 01 august 2019, it was reported from (b)(6) that an intellicart unit was giving off a burning smell; the account noted that the cart did not give an error code or shut down.The device was found to be conforming to manufacturer specification; no issues were found and there were no allegations of harm.Therefore, this investigation will be completed as a limited investigation.The dhr review and complaint history review are not required.On 01 august 2019, (b)(6) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and was unable to reproduce the reported event.He ran a wash cycle, and ran the vacuum pump for an hour with no abnormal smells.He noticed that the power iv pole icon wasn¿t on the screen, so he changed a setting to re-enable that feature.He then verified proper function and returned the cart to service.Per crm, a repair checklist was not required.Because the reported event was never confirmed during inspection of the device, and the device was noted to be functioning as intended, it is not known with the information available what caused the burning smell reported.Therefore, based on the information provided, a specific root cause cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.

Event Description

No additional event information.

• Brand Name: DUO FLUID CART WITH SMOKE EVAC AND POWER IV
• Type of Device: SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8876063
• MDR Text Key: 153886697
• Report Number: 0001526350-2019-00640
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

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: 0040441
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1