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 Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The incident unit has been requested but to date has not been received for evaluation.If the unit 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 Description

The customer reports that the screen goes black after turned on for over 5 minutes while connected to an iris feeding tube.The issue occurred during prep before the procedure was started, no patient involved.Another feeding tube and interface cable were tested with the same results.

• Brand Name: CONSOLE FOR IRIS FEEDING TUBES
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 8541909
• MDR Text Key: 142871665
• Report Number: 1282497-2019-08397
• Device Sequence Number: 1
• Product Code: KNT
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• 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: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1