MAUDE Adverse Event Report: TELEFLEX, INC. HUDSON RCI; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	IPN927526
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Respiratory therapist (rt) responded to vent alarming.Rt and the nurse assessed patient and equipment.Clinical staff found the vent circuit melted and fused together and created a 100% leak.After recognizing the issue, called a charge rt and changed the vent and the circuit.Issue was solved.Heater humidifier involved in incident was a trial neptune heater humidifier and circuit.After incident, patient was switched to hospital-owned fisher & paykel heater humidifier.Biomedical engineering inspected the equipment.The heater humidifier appears to have overheated the internal wire of breathing circuit.This caused the tubing to fuse together.Ventilator was also inspected, no issues found.

• Brand Name: HUDSON RCI
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX, INC.; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 19536582
• Report Number: 19536582
• Device Sequence Number: 12304969
• Product Code: BTT
• UDI-Device Identifier: 54026704728508
• UDI-Public: (01)54026704728508
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024
• Report Date (Section F): 03/04/2024

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 Model Number: IPN927526
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/04/2024