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

Model Number 386100

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/13/2023

Event Type  malfunction  

Event Description

It was reported that the screen is black/pixelated and will not turn on.When it is powered off the screen flashes white and goes completely dark.

Manufacturer Narrative

The device history record (dhr) was reviewed and was no failures associated with the reported condition observed.The manufacturing processes were reviewed and there were no abnormalities observed.The unit passed the test and visual inspection prior to releasing for shipment.The device was returned for investigation.An analysis was performed on the returned unit.The unit passed the physical appearances as there were no cosmetic issues found.Furthermore, there were no abnormalities found on the returned unit as the unit was able to power on the screen and start up to ¿language¿ mode.The console was able to login and passed the functional and inspection test.The root cause was not able to determined no failure was observed during the analysis.No corrective actions are needed at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: CONSOLE FOR IRIS FEEDING TUBES
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16315135
• MDR Text Key: 309386332
• Report Number: 1282497-2023-10732
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521164987
• UDI-Public: 10884521164987
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 386100
• Device Catalogue Number: 386100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1