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

Model Number N/A

Device Problems Melted (1385); Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record (dhr) for ultra duo flex fluid cart serial number (b)(4) was reviewed and 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 (b)(6) 2019, it was reported from (b)(6) that the unit would not power up when connected via wall or evac.On (b)(6) 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived and found there was no issue with connecting to the evac, but found the power inlet module melted.He proceeded to replace the power inlet module (part # 90204), then tested the unit to verify proper operation.The device was tested, inspected, and repaired.Service work order dms-50556-z1c2d8 on 18 mar 2019.The root cause of the reported event was due to a bad power inlet module.The power inlet module will supply power to the unit when it is connected to the power socket, if it is not functioning as intended it would not turn on the unit.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.(b)(4).Device evaluated by external contractor.

Event Description

It was reported that duo fluid cart would not power up as a result of a melted power inlet module.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: 8483663
• MDR Text Key: 147057119
• Report Number: 0001954182-2019-00023
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 0028014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• 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