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

Model Number N/A

Device Problems Device Emits Odor (1425); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).No code available for burning smell.The product will not be returned to zimmer biomet for investigation because the customer wants the product to be serviced on site.However, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery the unit had a burning smell during cases.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).The previous repair report for ultra duo flex fluid cart, 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 report review found no issues with the device after repair 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 1 time, the previous repair being on 5 may 2017 for the monitor not turning on.The monitor issue was not associated with the current repair service which is related to no problem found, so the previous repair was a non-related issue.The complaint history review was not required since the repair technician could not reproduce the reported event or find any other issues with the device.On 18 april 2017, it was reported from (b)(6) hospital that a cart unit has a burning smell during cases.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on (b)(4) 2017 and found unit with no smell.The technician checked error log for over temperature and none found, checked for highest temp and found it was still the high temp from factory testing, adjusted lower sound material as they did appear to be close to the vacuum pump but found no signs of burning or heating and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.No repair checklist was required as per crm.Service work order (b)(4) on 18 april 2017.The repair technician could not reproduce the reported event or find any other issues with the device.Therefore, based on the information provided, the 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.

• 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
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6758473
• MDR Text Key: 81574341
• Report Number: 0001954182-2017-00009
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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: 00514010200
• Device Lot Number: 0025012
• Other Device ID Number: (01)00889024466005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1