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

Model Number RT380

Device Problems Air Leak (1008); Crack (1135)

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

Event Date 10/23/2016

Event Type  malfunction  

Manufacturer Narrative

Method: only the expiratory limb of the complaint rt380 evaqua2 adult breathing circuit was received at fph in (b)(4) for evaluation and was visually inspected.Our investigation is also based on additional information provided by the hospital, our knowledge of the product and previous investigations of similar complaints.Results: visual inspection of the expiratory limb revealed that a section of the tubing was degraded.A lot check could not be performed as no lot information was provided.Conclusion: the hospital reported that the subject rt380 adult breathing circuit had been used for a month and a half.The rt380 adult breathing circuit is intended to be used for a maximum of 14 days as per our user instructions.The degraded expiratory limb was most likely due to excessive use.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject rt380 adult breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt380 breathing circuit state: this product is intended to be used for a maximum of 14 days.Do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.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 hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that a leak was detected on the rt380 evaqua2 adult breathing circuit.It was also reported that the expiratory limb of the subject breathing circuit had a crack.No patient consequence was reported.

• Brand Name: ADULT 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6127077
• MDR Text Key: 60878037
• Report Number: 9611451-2016-00802
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: NP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Date Manufacturer Received: 10/27/2016
• 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
• Treatment: VELA VENTILATOR