MAUDE Adverse Event Report: COVIDIEN CONSOLE FOR IRIS FEEDING TUBES; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 386100

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is underway.The results will be shared upon completion.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the device stopped working and the screen turned off during placement.The clinician checked and replaced the power adapter connections and the interface cables, but the screen would not turn on.Additional information was received that the screen did not freeze, the screen went black and they could not get it to light back up.There was no patient harm.

Manufacturer Narrative

There was no service history available as this was the first time the unit was returned for service.The device was evaluated and a failure analysis was performed; the device was found to have a crack on the multi-touch panel and also there was no response on the multi-touch panel.In addition, it was also observed to have a crack on and burn mark on the component.The suspected reported issue may be due to mishandling of the device at the end user facility.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of the device.If additional information is received, the investigation will be reopened and responded to accordingly.

• Brand Name: CONSOLE FOR IRIS FEEDING TUBES
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11802611
• MDR Text Key: 250348115
• Report Number: 1282497-2021-10166
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521164987
• UDI-Public: 10884521164987
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 386100
• Device Catalogue Number: 386100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2021
• Patient Sequence Number: 1