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

Model Number N/A

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous work order ((b)(4)) of intellicart system unit 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 by zimmer biomet surgical 5 times.The last repair was done for power issue and it is related to the current repair.On (b)(6) 2019, it was reported from (b)(6) hospital that power inlet module was melted and fuses were melted.The zimmer biomet authorized service technician from (b)(4) arrived at the site on (b)(6) 2019, evaluated the unit and confirmed the reported event.He then replaced power inlet module but the cart does not power on.He again arrived at the site on (b)(6) 2019 replaced 10 amp fuses and confirmed that the unit was functioning as intended.The service technician returned the unit back to service without any further concerns.The unit was tested, inspected, and repaired.Service work order (b)(4) on (b)(4) 2019.The root cause of the reported event was due to bad fuse.If the fuses are blown, it would not turn on unit and will melt power inlet module.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the fuse was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Device evaluated by external contractor.

Event Description

It was reported that duo fluid cart power inlet module was melted and fuses blown.The event timing was during cleaning.No adverse events were reported as a result of this malfunction.

• 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
• 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: 8470842
• MDR Text Key: 146524601
• Report Number: 0001954182-2019-00022
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 00514010100
• Device Lot Number: 0024394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1