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

Model Number RT265

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare representative that the swivel elbow easily detached from the swivel wye of an rt265 infant dual-heated evaqua2 breathing circuit after four days of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: only the swivel wye of the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The returned swivel was visually inspected and pressure tested.Results: visual inspection revealed a crack in the swivel wye and scuff marks on the rim of the connector.The circuit was pressure tested and revealed that it was out of specification.A lot check was not performed as a lot number was not provided.Conclusion: based on the appearance of the observed damage to the swivel, it appears likely that the cracking was caused by some form of physical impact.The customer has confirmed that the subject breathing circuit was in use for four days before the issue was observed, which indicates that the circuit became damaged during use.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.Our user instructions that accompany the rt265 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: 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4260394
• MDR Text Key: 5048386
• Report Number: 9611451-2014-00870
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• 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: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2014
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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