MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number IPN913687

Device Problems Loose or Intermittent Connection (1371); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/16/2020

Event Type  malfunction  

Event Description

The therapist was testing a ventilator with her students and noticed several circuits failed the leak test.They inspected the circuits and tested the same circuit on a different vent, ruling out the vent as the issue.Therapist brought it to the charge therapist and he too noticed the vent fail and upon inspection of the circuit, noted it was seemingly different from our other circuits with a different lot number, and that the distal port was loose on all of them.

• Brand Name: HUDSON RCI
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 10319465
• MDR Text Key: 200214502
• Report Number: 10319465
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IPN913687
• Device Catalogue Number: 1613
• Device Lot Number: 14E2000873
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1