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

Model Number	386100
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11802611
• Report Number: 1282497-2021-10166
• Device Sequence Number: 19800574
• Product Code: KNT
• UDI-Device Identifier: 10884521164987
• UDI-Public: 10884521164987
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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
• Operator of Device: No Information
• Device Model Number: 386100
• Device Catalogue Number: 386100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 10/08/2021
• Patient Sequence Number: 1