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

Model Number N/A

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

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

It was reported that the cart fluid had started to count backwards.It was stated that the reported issue was noticed during cleaning.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report additional information.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.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired once, the previous repair being for an issue with the carbon filter on 20 november 2017.The carbon filter is not associated with the current repair.Thus, this repair was a non-related issue.Using view 09-23 from the etq reliance system, there was 01 complaint that contained part number: 00514010200 lot# 0025196 and complaint description with the keyword: ¿count backward.¿ the highest occurrence for a given manufacture date was 02.The keyword of ¿count backward¿ was chosen as a filter based upon the reported failure of ¿fluid had started to count backwards.¿ using view 09-23 from the etq reliance system, there were 02 complaints from 09 may 2017 to 06 june 2018 that contained part number: 00514010200, complaint description with the keyword: ¿count backward.¿ the keyword of ¿count backward¿ was chosen as a filter based upon the reported failure of ¿fluid had started to count backwards.¿ on 21 may 2018, it was reported from valley hospital medical center that fluid had started to count backwards.Silver reef biomedical services was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site initiated an exchange at the request of the sales team.A new cart was shipped from riverside, and the replacement cart was noted to be delivered on 24 may 2018.Silver reef biomedical services dispatched a service technician to the site to perform the exchange.On 24 may 2018 the service technician confirmed that the exchange was completed and that the exchanged unit was packaged and ready for return.The exchange cart was picked up from the facility on 24 may 2018 and was confirmed that it was returned to riverside on 04 june 2018.The cart was refurbished as noted.A returned equipment log.Per (b)(4) riverside completed an additional assessment of the cart and was unable to find any issue with the cart.A returned part evaluation was conducted on the returned intellicart.No problem was found with the unit.No additional information is available at this time.Service work order (b)(4) 21 may 2018.The reported event was never confirmed during inspection of the device and after the device was exchanged no problem was found with the unit.Therefore, the root cause could not 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
• MDR Report Key: 7567555
• MDR Text Key: 110045546
• Report Number: 0001954182-2018-00034
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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)00889024466005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1