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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL CONCHA-COLUMN; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
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.
 
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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 Key4549133
MDR Text Key5524565
Report Number4549133
Device Sequence Number1
Product Code BTT
Reporter Country CodeUS
Number of Events Reported1
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 FDA02/10/2015
Event Location Hospital
Date Report to Manufacturer02/26/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight114
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