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

Catalog Number 00514010100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.Evaluated by external contractor.

Event Description

It was reported that after surgery that there was a burning electrical smell coming from the cart.There was no harm involved.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi no: (b)(4).On 14 october 2019, the regional service manager requested that an exchange unit be sent to this account due to the frequency of the odor complaints at this account.The exchange was written and submitted prior to technician dispatch.Per crm, a repair checklist was not required.The new cart (serial # (b)(4)) was shipped from riverside and arrived at the account on 17 october 2019.Cumberland biomedical services was contacted about the exchange and dispatched a service technician to be at the site.The technician arrived at the site and completed the exchange, noting the new unit was in service without issue.The old cart was shipped back to riverside and arrived on 22 october 2019.The cart was noted to be returned for reported odor issues.The cart is to be refurbished with new serial number (b)(4).No additional information is available at this time.Because the reported event of the unit having an odor was not confirmed as a technician was not dispatched to evaluate it prior to being exchanged, it is not definitively known with the information available what caused the reported odor issues.Previously noted vacuum pump burn-in scent was not noted to be a culprit in this instance.Therefore, based on the information available, a specific root cause of the reported event 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 for any adverse trends that may require additional actions.

• 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
• MDR Report Key: 9286426
• MDR Text Key: 199703938
• Report Number: 0001954182-2019-00070
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010100
• Device Lot Number: 0025144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1