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

Catalog Number 880-15KIT

Device Problems Melted (1385); Material Puncture/Hole (1504); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2018

Event Type  malfunction  

Event 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
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 7973771
• MDR Text Key: 123990205
• Report Number: 7973771
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 880-15KIT
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1