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 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).No code available for electrical smell.The product will not be returned to zimmer biomet for investigation because it was evaluated by an external contractor.However, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product evaluated by external contractor.

Event Description

It was reported that during cleaning the cart had a "hot electrical smell." no adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).The previous repair report for intellicart, 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 once, the previous repair being for vacuum sensor 1 errors on (b)(6) 2016.The vacuum pump issue was not associated with the current repair service which is related to hot electrical smell from the cart, so the previous repair was a non-related issue.On (b)(6) 2017, it was reported from (b)(6) hospital that a cart is making a hot electrical smell.(b)(6) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on (b)(6) 2017 and was unable to find any problem with the device.Verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired without any repair checklist as per crm.Service work order (b)(4) on (b)(6) 2017.The service technician could not reproduce the reported event or find any other issue with the device.Therefore, based on the information provided, 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.

• 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: 6786257
• MDR Text Key: 82788497
• Report Number: 0001954182-2017-00013
• 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: 08/31/2017

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: 0025196
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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