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

Model Number RT266

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6), reported via our distributor that swivel wye on an rt266 infant dual-heated evaqua2 breathing circuit is loose and falls off unless it is tightened prior to use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).We have recently received a device from the healthcare facility for investigation.Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint device was returned to fisher & paykel healthcare in (b)(4) where it was visually examined and pressure tested for any leaks.Results: visual inspection did not reveal any damage to the returned rt266 infant evaqua2 breathing circuit.Pressure test revealed that the returned circuit was within specification.A lot check revealed no other complaints of this nature for lot number 140829.Conclusion: we are unable to determine what may have caused the reported problem.No fault was found with the returned rt266 infant evaqua2 breathing circuit.All rt266 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt266 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 healthcare facility in (b)(6), reported via our distributor that swivel wye on an rt266 infant dual-heated evaqua2 breathing circuit is loose and falls off unless it is tightened prior to use.No patient consequence was reported.

• 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: 4278159
• MDR Text Key: 5224450
• Report Number: 9611451-2014-00885
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 140829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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