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

Model Number RT380

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 circuit has recently been received at fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We are in the process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a distributor that two rt380 adult dual heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.

Event Description

A healthcare facility in japan reported via a distributor that two rt380 adult dual heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: two complaint rt380 adult evaqua 2 breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where they were visually inspected and pressure tested.Results: visual inspection revealed no damage to the returned breathing circuits or dryline.The pressure test revealed that the both subject breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the leak as reported by the customer as no fault was found with the returned devices.All rt380 adult 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 specifications at the time of production.Our user instructions that accompany the rt380 adult 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.'.

• Brand Name: ADULT 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
• MDR Report Key: 8188235
• MDR Text Key: 131930781
• Report Number: 9611451-2018-01112
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 2100488729, 2100488065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1