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

Model Number RT266

Device Problems Device Issue (2379); Split (2537)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining the complaint rt266 infant dual-heated evaqua2 breathing circuit from the hospital for evaluation, to determine if it had a malfunction which might have caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) representative that an rt266 infant dual-heated evaqua2 breathing circuit had split at the seam during use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the hospital reported one complaint rt266 infant dual-heated evaqua2 breathing circuit but returned two devices to fph in (b)(4) for evaluation under this complaint reference.The returned breathing circuits were visually inspected and pressure tested.Results: visual inspection of device 1 revealed a white split on the inspiratory limb while multiple splits were observed in device 2.Stress marks were also noted along the grooves of the inspiratory limbs of both devices.The pressure test result was outside of specification in both devices.Conclusion: we are unable to determine the root cause of the fault reported by the hospital.However based on our investigation, the subject inspiratory limbs appear to have been scratched by a sharp object.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 subject breathing circuit would have met the required specification prior to distribution.Our user instructions that accompany the rt266 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 occlusions before connecting to a patient." - "set appropriate ventilator alarms." - "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.".

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) representative that an rt266 infant dual-heated evaqua2 breathing circuit had split at the seam during 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: jon stevens ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6244597
• MDR Text Key: 64589184
• Report Number: 9611451-2017-00007
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• 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