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

Model Number RT380

Device Problem Crack (1135)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 circuit was returned to fisher & paykel healthcare in (b)(4) for investigation.The returned device was visually inspected.Results: visual inspection revealed that the collar at the patient end of the expiratory limb was cracked along its length.Conclusion: we were unable to determine conclusively what had caused the collar to crack; however, based on our previous investigations it is possible that the crack is due to being in contact with a chemical solution, resulting in environmental stress cracking.As the damage occurred after 13 days of use, we can conclude that the circuit was originally functioning correctly.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 user instructions that accompany the rt380 breathing circuit state: - 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 healthcare facility in (b)(6) reported via a distributor that they found a crack on the collar of the expiratory limb of an rt380 evaqua2 adult breathing circuit after 13 days of patient use.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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 7147022
• MDR Text Key: 96021597
• Report Number: 9611451-2017-01245
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• 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