MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problems Gas/Air Leak (2946); Component Misassembled (4004)

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

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 infant dual heated evaqua2 breathing circuit is currently en route to f&p (b)(4) for investigation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that an rt266 infant dual-heated evaqua2 breathing circuit had a leak in the circuit.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation where it was visually inspected.Results: visual inspection revealed that an incorrect connector was assembled to the returned dryline circuit.Conclusion: the incorrect connector would not fit into the ventilator.A lot check revealed no other complaints of this nature for lot number 2100817606.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing cicuit state the followings: - 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.

Event Description

A healthcare facility in ireland reported that an rt266 infant dual-heated evaqua2 breathing circuit had a leak in the circuit.There was no reported patient consequence.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9294097
• MDR Text Key: 178583078
• Report Number: 9611451-2019-01083
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2100817606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERVO I VENTILATOR; SERVO I VENTILATOR