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

Catalog Number 00514010200

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

This unit is not powering on and there is a burning smell.Evening timing was after the surgery during cleaning.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(6).Udi: (b)(4).On 13 september 2019, it was reported from canada - hamilton general hospital that an intellicart unit had a burning smell and would not power on.The device history record (dhr) for intellicart system serial number 1180352 was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 13 september 2019, it was reported from canada - hamilton general hospital that an intellicart unit had a burning smell and would not power on.On 13 september 2019, customer service ¿ canada was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and could not confirm the odor but was able to confirm the cart not powering on.He replaced the power inlet module fuses but noted they failed again, denying the cart power still; the module itself had failed.He also replaced the power iv pole clamp (part #70195) on this unit.He returned on a later date and replaced the power inlet module (part #90204) and its fuses (part #90562) and noted the unit powered on correctly.He then found the cylinder 2 tint had gone bad, so he installed new cylinder tint (part #70073 and lot code #0041414 and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 13 september 2019.Because the reported event of a burning smell was unable to be confirmed during inspection of the device, it is not known with the information available what cause the reported burning smell.Therefore, based on the information provided, a specific root cause of the burning smell cannot be determined.In addition, the root cause of the unit not powering on was due to a malfunctioning power inlet module.The power inlet module is the location of the ac power inlet, power switch, and fuses for the cart.The power inlet module failing would deny the cart power.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet module, its fuses, the power iv pole clamp, and the cylinder tint were replaced.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 (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9075196
• MDR Text Key: 195986518
• Report Number: 0001954182-2019-00057
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

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 Catalogue Number: 00514010200
• Device Lot Number: 0027736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1