MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RCI; TUBE, TRACHEAL

Model Number IPN044768

Device Problems Unintended Ejection (1234); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

Staff has had the ett fortlight adapters popping out issue rear its ugly head again.There were 2 patients in the cvicu today who had an issue.The tubes remain in.

• Brand Name: HUDSON RCI
• Type of Device: TUBE, TRACHEAL
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 7645555
• MDR Text Key: 112592812
• Report Number: 7645555
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN044768
• Device Catalogue Number: 5-10316
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA