MAUDE Adverse Event Report: TELEFLEX MEDICAL GIBECK HME HUMID-VENT 2S; CONDENSER, HEAT AND MOISTURE

Catalog Number 17731

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  No Answer Provided  

Event Description

Black discoloration noted in a portion of the hme (heat and moisture exchanger) connected to ventilator tubing/ett.Removed.Did not appear to affect ventilation or impact patient.

• Brand Name: GIBECK HME HUMID-VENT 2S
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; po box 12600; durham NC 27709
• MDR Report Key: 4095652
• MDR Text Key: 4832932
• Report Number: 4095652
• Device Sequence Number: 1
• Product Code: BYD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: 17731
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ETT IN USE BUT UNKNOWN IF CONTRIBUTED; VENTILATOR
• Patient Age: 52 YR