MAUDE Adverse Event Report: TELEFLEX MEDICAL CONCHA-COLUMN; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The heater used on a heated tracheostomy collar was found not functioning properly causing an alarm.The respiratory therapist noted the humidifier chamber was empty and he was unable to fill it.The therapist noted the fill tube on humidifier was obstructed with a foreign body.The foreign body appeared to be plastic and likely originated from the manufacturing process.The item was removed from service and sequestered.

• Brand Name: CONCHA-COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; 2400 bernville road; reading, PA 19605
• MDR Report Key: 4549133
• MDR Text Key: 5524565
• Report Number: 4549133
• Device Sequence Number: 1
• Product Code: BTT
• 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: 02/10/2015

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?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 114