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

Model Number RT202

Device Problem Disconnection (1171)

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

Event Date 05/20/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare representative that an rt202 adult inspiratory-heated breathing circuit became disconnected at the connection between the mr290 chamber and the circuit.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint rt202 breathing circuit was not returned to fisher & paykel healthcare (b)(4) for evaluation.Only limited information was provided by the hospital, namely that the inspiratory limb of the subject circuit became disconnected from the mr290 chamber.Without the complaint breathing circuit we are unable to determine whether it had any defect.The hospital did however provide information indicating that the reported incident was related to transferring the patient to another room.They further admitted that it is possible that the circuit was accidentally pulled, which could have led to the reported disconnection.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.Our user instructions that accompany the rt202 adult dual-heated breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms.".

• Brand Name: ADULT INSPIRATORY HEATED 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3889252
• MDR Text Key: 4673478
• Report Number: 9611451-2014-00538
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2014

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 Operator: Health Professional
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/23/2014
• 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 HEALTHCARE MR850 HUMIDIFIER; FISHER & PAYKEL HEALTHCARE OPTIFLOW CANNULA