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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI CONCHATHERM NEPTUNE; HUMIDIFIER, RESPIRATORY GAS
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TELEFLEX INCORPORATED HUDSON RCI CONCHATHERM NEPTUNE; HUMIDIFIER, RESPIRATORY GAS Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2019
Event Type  malfunction  
Event Description
Found a bipap machine in the ed hallway, not in a pt's room.The machine seemed like it was use on a pt and put outside in the hallway after use.The circuit appear melted/burned.Brought it down to department and put a defective sticker on it.Respiratory investigation: i have interviewed the 2 rt's taking care of the er the morning the machine circuit in question was found.I am working with clinical engineering to complete their safety check and testing.I have notified the circuit company and they would like to have us send them the circuit asap for their internal investigation once we are done with our investigation.I have the burned circuit in question.
 
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Brand Name
HUDSON RCI CONCHATHERM NEPTUNE
Type of Device
HUMIDIFIER, RESPIRATORY GAS
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key9309501
MDR Text Key165971293
Report Number9309501
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/16/2019
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 No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/16/2019
Event Location Hospital
Date Report to Manufacturer11/12/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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