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 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been evaluated by an external contractor and the investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It has been reported that the cart had a burning smell.The event timing was during cleaning.There was no patient involvement.No adverse events have been 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 : (b)(4).On 19 december 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site but could not find any issue with the cart.The technician verified that the unit was functioning as intended then returned the unit to service without further incident.The reported event could not be confirmed during inspection of the device; therefore, the root cause for the unit having a burning smell could not be determined.The device was noted to be functioning as intended and no problem was found.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.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

• 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: 9581207
• MDR Text Key: 194601401
• Report Number: 0001954182-2020-00002
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 0024489
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1