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

Model Number RT265

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that an rt265 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test.The hospital reported that the replacement circuit also failed the ventilator leak test and hospital staff found the inspiratory and expiratory tubing loose at the patient end.A third circuit was reported as having failed the ventilator leak test and the duck bill valve was found disconnected.A member of staff found the round valve in two pieces on another circuit and had to snap them back together.No patient consequence was reported as this occurred before patient use.

Manufacturer Narrative

(b)(4).Method: the four complaint rt265 infant dual-heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare in (b)(4) for evaluation.Despite requests for the complaint devices to be returned the hospital disposed of the circuits.However the hospital was able to return a number of unopened rt265 breathing circuits for investigation.Eleven breathing circuits were pressure tested and visually inspected for damage.Our investigation is based on the event description, investigation of the returned unopened devices and our knowledge of the product.Results: no damage was found to any part of the returned unopened rt265 breathing circuits.The pressure test revealed that all of the eleven tested circuits were within specification.Conclusion: without the return of the complaint devices we are unable to determine what may have caused the problems experienced by the customer.In addition, we could find no fault with the unopened circuits returned by the hospital.If the breathing circuit connections are not tight a leak may develop.All rt265 breathing circuits are pressure tested before leaving the production line and those that fail are discarded.It is therefore most likely that the damage occurred after leaving our production facility.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusion 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 LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 3735100
• MDR Text Key: 18364178
• Report Number: 9611451-2014-00308
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2014
• 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