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

Catalog Number UE514010100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

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 during cleaning the cart was giving off a burning smell.There was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi #: (b)(4).4316: event was caused by the new vacuum pump smell wearing off.The previous repair record for intellicart system serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 5 times, the previous repair being for the vacuum pump not working on 26 september 2019.The vacuum pump is associated with the current repair.Thus, this repair was a related issue.On 7 october 2019, it was reported from (b)(6) center that the cart was giving off a burning smell.On 7 october 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On 8 october 2019, the technician arrived at the site and confirmed that there was a smell from the cart.The technician noted the vacuum pump was recently changed and the cart was run to get the new pump smell to burn off then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.Service work order (b)(4) on 7 october 2019.The root cause for the strong electrical burning smell was due to a newly replaced vacuum pump.When replaced, the vacuum pump can emit an odor that when run continuously, will dissipate over time.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the vacuum pump was run.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information available.

• Brand Name: DUO FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9215947
• MDR Text Key: 199704071
• Report Number: 0001954182-2019-00066
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1