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

Model Number 5-10312

Device Problem Disconnection (1171)

Patient Problems Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2018

Event Type  malfunction  

Event Description

Reported by nurse: the patient is intubated with an endotracheal tube (ett).She is on the ventilator on pressure support ventilation mode.The connection between the ett and the vent tubing (direct connection between ett and tubing) comes disconnected spontaneously.As i write this, at 1600, it has happened 19 times, including, while at ct scan and the patient's pulse ox dropped to 91% before i could reach the patient.I have also witnessed it occur without the patient moving or coughing, it literally disconnects without any sort of manipulation or cause.In the package, the ett comes pre connected to a connecter piece, those are the two pieces that are becoming disconnected.

• Brand Name: HUDSON RCI
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL INC.; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 7486621
• MDR Text Key: 107370233
• Report Number: 7486621
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-10312
• Other Device ID Number: SIZE 7.5 ETT
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR