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

Catalog Number 00514010100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi #: (b)(4).On (b)(6) 2019, it was reported from (b)(6) medical center that an intellicart unit would not power on the monitor.The previous work order in customer relationship management (crm) 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 work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) medical center that an intellicart unit would not power on the monitor.On 14 august 2019, c3 tech, llc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed power issues, noting that the cart would not power on when plugged into an outlet.He also noted a clicking noise and burning smell/ the technician replaced the power inlet module (part #90204) and the appropriate fuses (part #90562) and 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 (b)(4) on 14 august 2019.The root cause for the unit not powering on was due to a failed power inlet module.The power inlet module is where the ac power cable plugs into the unit and also houses the fuses for the cart.The module failing would prevent the cart from getting power, and the unit would not turn on at all.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 and its fuses were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.

Event Description

It was reported that the unit would not power on the monitor.The event timing was before surgery.The investigation revealed the unit had a burning smell.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: 8945099
• MDR Text Key: 207034429
• Report Number: 0001954182-2019-00053
• 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: 08/29/2019

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 Catalogue Number: 00514010100
• Device Lot Number: 0024178
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• 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