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

Model Number RT266

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt266 breathing circuit was not returned to fisher & paykel healthcare for evaluation as it was discarded.Our investigation is thus based on the customer's description of events, inspection of a photograph provided by the customer, and our knowledge of the product.The customer reported that the swivel piece came apart when the patient was being turned around and noted that there was no damage to the swivel.Conclusion: the disconnection of the swivel piece is possibly a result of undue tension on the circuit during repositioning of the patient.Our user instructions state to "check all connections are tight before use." 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 (b)(6) reported via a fisher and paykel healthcare field representative that the swivel of an rt266 infant dual-heated evaqua2 breathing circuit came apart while the patient was being turned around.There was no 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7124627
• MDR Text Key: 95216854
• Report Number: 9611451-2017-01208
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• 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