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

Model Number	386100
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1282497-2023-10732
• Device Sequence Number: 12189539
• 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,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 386100
• Device Catalogue Number: 386100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown