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

Model Number RT266

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 infant dual heated evaqua2 breathing circuit has yet not been returned to fisher & paykel healthcare for evaluation.We are currently attempting to obtain the rt266 and will provide a follow-up report upon evaluation of the device.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the swivel wye of an rt266 infant dual heated evaqua2 breathing circuit had disconnected from the circuit during set-up.There was no patient involvement.

Manufacturer Narrative

Ps295624 the complaint rt266 breathing circuit was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the customer's description of events, and our knowledge of the product.The customer reported that the swivel piece had disconnected from the circuit during setup.Conclusion: we are unable to determine the cause of the reported disconnection without the complaint device.The infant swivel elbow and swivel wye are assembled using a machine to ensure a consistent tightness of connection.The swivel assembly is then 100% pressure and flow tested as part of the infant breathing circuit before leaving the production line.Any circuits that fail these tests are rejected.The user instructions that accompany the rt266 also 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.

Event Description

A hospital in the uk reported via a fisher & paykel healthcare (f&p) field representative that the swivel wye of an rt266 infant dual heated evaqua2 breathing circuit had disconnected from the circuit during set-up.There was no patient involvement.

• 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: 8205104
• MDR Text Key: 131943843
• Report Number: 9611451-2018-01135
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1