MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT; BZE

Model Number RT345

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/07/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that an rt345 adult dual heated evaqua breathing circuit failed the evita4 ventilator leak test.This was observed prior to patient use.

Manufacturer Narrative

(b)(4).The rt345 adult dual heated evaqua breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt345 breathing circuit was returned to fisher & paykel healthcare (fph) in (b)(4) and was visually inspected.Results: visual inspection revealed that the evaqua expiratory limb had a hole approximately 5cm from the patient end connector.A lot check revealed no other complaints for lot date 131029.Conclusion: based on our visual inspection, the subject expiratory limb appears to have been punctured with a blunt object.All rt345 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails is discarded.In addition, tube weighing and bond strength testing are performed every 15 minutes.If any faults are detected the whole batch is placed on hold for investigation.This suggests that the subject breathing circuit was damaged after it was released for distribution.The key difference between the evaqua breathing circuits and conventional breathing circuits is that the expiratory limb of the evaqua circuits such as the rt345 is composed of a thin, semi-permeable film specially designed to allow water vapour from expired ventilatory gas to pass through.The evaqua expiratory tube has a protective mesh which prevents damage to the walls of the tube, however the evaqua tubing can be more susceptible to damage than conventional circuits when exposed to rough handling or damage caused by sharp and blunt objects and non-fph circuit hangers.The user instructions that accompany the rt345 adult dual heated evaqua breathing circuit state the following: - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarms." - "fit only the supplied fisher & paykel healthcare circuit hanger with care to avoid circuit damage.".

• Brand Name: ADULT DUAL HEATED EVAQUA 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: 3839495
• MDR Text Key: 4411908
• Report Number: 9611451-2014-00476
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT345
• Device Catalogue Number: RT345
• Device Lot Number: 131029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2014
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2013
• 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
• Treatment: EVITA4 VENTILATOR