MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problems Leak/Splash (1354); Gas/Air Leak (2946); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in process of obtaining further information from the customer in order to determine if fisher & paykel healthcare product's 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 that "the connecting port of an rt380 adult dual heated evaqua2 breathing circuit was sliding" and caused gas leak during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer stated that an f&p rt380 adult dual- heated evaqua2 breathing circuit "connecting port was sliding" resulting in a leak in the circuit.Conclusion: without the complaint device, we are unable to confirm the cause of the reported event.All rt380 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.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.".

Event Description

A healthcare facility in china reported via a fisher & paykel healthcare (f&p) field representative, that a rt380 adult dual-heated evaqua2 breathing circuit "connecting port was sliding" and the circuit was found to be leaking.There was no reported patient consequences.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 10833997
• MDR Text Key: 217462872
• Report Number: 9611451-2020-01019
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: 010942001242972810
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: 2100850248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2019
• 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