MAUDE Adverse Event Report: TELEFLEX MEDICAL GIBECK HUMID-FLO; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number 19912

Device Problems Leak/Splash (1354); Device Inoperable (1663)

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

Event Date 11/20/2016

Event Type  malfunction  

Event Description

Patient found to have recurring leak on the ventilator.During problem shooting at the bedside hme was changed and the leak was resolved immediately.It seems as though the hme was not functioning properly.It had been in use since the patient was intubated during the same day.

• Brand Name: GIBECK HUMID-FLO
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 6236275
• MDR Text Key: 64289910
• Report Number: 6236275
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 19912
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR