MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT BREATHING CIRCUIT; BTT

Model Number RT202

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The hospital did not provide an rt202 breathing circuit or mr290 chamber for evaluation as they were not reporting any defect of the devices.Rather, this was a general complaint concerning the circuit disconnecting from the chamber when put under excessive strain as a result of pulling on the system or having it caught on a bed that is being raised.Based on the description of events provided by the hospital, we can conclude that the rt202 circuit and the mr290 chamber were operating correctly but had disconnected when under excessive pulling force.When properly connected the circuit and chamber form a tight fit and cannot disconnect spontaneously.The connection between the circuit elbow and chamber port is a standard medical taper fit and conforms to iso (b)(4): anaesthetic and respiratory equipment -- conical connectors.All breathing circuits chambers are pressure tested for leaks during production and those that fail are rejected.The user instructions that accompany the rt202 adult breathing circuit contain the following: check all connections are tight before use.Set appropriate ventilator alarms.Do not stretch or milk the tubing.

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare representative that the rt202 adult inspiratory heated breathing circuit occasionally disconnects from the mr290 humidification chamber port when pulled on or caught on a bed that is being raised.They commented that patients would desaturate but recover fully.

• Brand Name: ADULT BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 5969070
• MDR Text Key: 55324200
• Report Number: 9611451-2016-00583
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL MR290 HUMIDIFICATION CHAMBER