MAUDE Adverse Event Report: COVIDIEN LLC SHILEY¿ EVAC ENDOTRACHEAL; TUBE, TRACHEAL

Model Number 18875

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Loss of consciousness (2418)

Event Date 06/15/2018

Event Type  Injury  

Event Description

During daily care, vent tubing became dislodged from ett.As the connector for the ett fits perfectly into the esophageal temperature probe, the vent was inadvertently hooked up to the esophageal temp probe thereby ventilating the esophageal temp probe.This lasted for 10 minutes when the patient coded and the error was discovered.Patient was resuscitated.

• Brand Name: SHILEY¿ EVAC ENDOTRACHEAL
• Type of Device: TUBE, TRACHEAL
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7666137
• MDR Text Key: 113320431
• Report Number: 7666137
• Device Sequence Number: 1
• Product Code: JOH
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 18B01729JZX
• 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: 06/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29930 DA