MAUDE Adverse Event Report: TELEFLEX MEDICAL CONCHATHERM NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number	880-15KIT
Medical Device Problem Codes	Melted (1385); Material Puncture/Hole (1504); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Vent was auto cycling, rt investigated and found the circuit was melted in 2 areas.Replaced circuit with bag valve mask ventilation to patient.Condensation in circuit.Temp probe was on outside of giraffe.Yellow pigtails that plug into heater were on top of vent circuit.Rt moved them and noticed holes.

• Brand Name: CONCHATHERM NEPTUNE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 7973771
• Report Number: 7973771
• Device Sequence Number: 1603548
• Product Code: BTT
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/02/2018
• Report Date (Section F): 10/02/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 880-15KIT
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/02/2018