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

Model Number	386100
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been requested but to date has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.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 before placement, they were logging into the iris console.The device would allow them to enter the login information and get to the screen with the four icons but, when they press the patient icon, the screen glitch then shut down completely.The issue occurred twice.Additional information was received stating that the screen froze for a moment and went back to normal then turned off.There was a slight delay in getting the tube placed although, no patient was involved yet.

• 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: 11712924
• Report Number: 1282497-2021-10100
• Device Sequence Number: 4220392
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1