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

Catalog Number UE514010100

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed as an initial final report based on findings from the device evaluation.Udi - (b)(4).Reported issue: the reported event for the device, as provided by the customer, was that the unit would not power on via the wall outlet.Dhr review: the previous repair report for intellicart 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.On 17 september 2019, it was reported from hackensack university medical center that the unit would not power on via the wall outlet.On 17 september 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site and confirmed that the unit was unable to power on via the wall outlet, and found that the power inlet fuses were bad.The technician noted the user hangs the power cord from the iv pole when not in use, and that it appeared that fluid had traveled down the cord and into the power let module, as it was corroded.The technician attempted to replace the inlet module fuses and found that the fuse holder was melted and then technician replaced the power inlet module (part #90204) to resolve the issue.The technician then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order dms-54660-q6c0s3 on 17 september 2019.The root cause for the reported event of the unit having no power was due to a bad power inlet module fuse.The unit¿s power inlet module directs the flow of electrical current the cart receives when plugged into and ac wall outlet.Without a proper functioning fuse the power inlet module is unable to redirect the provided current to power on the cart.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet module was replaced the investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

Event Description

It was reported that the unit would not power on via the wall outlet.Customer had not attempted it at the evac and was not near the unit.The event timing was pre-surgery.Per the investigation, that it appeared that fluid had traveled down the cord and into the power let module, as it was corroded.No adverse events were reported as a result of this malfunction.

• Brand Name: DUO FLUID CART - REFURBISHED
• 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: 9186740
• MDR Text Key: 191757128
• Report Number: 0001526350-2019-00876
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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