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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL CONCHASMART; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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TELEFLEX MEDICAL CONCHASMART; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Device Problems Circuit Failure (1089); Melted (1385); Device Displays Incorrect Message (2591)
Patient Problem Burn(s) (1757)
Event Date 01/26/2016
Event Type  Injury  
Event Description
Heated tracheostomy collar noted to be alarming.Blue tubing to collar noted to be melted.The patient had a red mark on her upper left arm - question a burn.No open areas noted at time of incident.Tubing also noted to be resting on blue turn system.Diagnostic tests of the humidifier were conducted in accordance with the manufacturer's written procedure.The device passed the display accuracy test and the functional test.The device was left operational for 3 hours with no malfunctions noted.A new patient heated-wire breathing circuit assembly inspiratory limb was used during the testing.The temperature probe that was being used when the incident occurred was used during the testing procedure and was found to be working properly.The failed circuit was retained by the hospital and the humidifier was returned to service after thorough testing/inspection as mentioned above.
 
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Brand Name
CONCHASMART
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key5466187
MDR Text Key39221047
Report Number5466187
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age26 YR
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