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

Model Number RT380

Device Problems Break (1069); Crack (1135)

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

Event Date 02/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 adult dual-heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that a rt380 adult dual heated evaqua2 breathing circuit was damaged.There was no reported patient involvement.

Event Description

A healthcare facility in france reported that a rt380 adult dual heated evaqua2 breathing circuit was damaged.There was no reported patient involvement.

Manufacturer Narrative

Ps377562, method: the complaint rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned circuit confirmed that the patient end evaqua2 collar was cracked.Further analysis of the returned complaint device revealed the surface of the collar had tree-ring like deformation pattern that is typical of environmental stress cracking which form due to chemical exposure or contact.Conclusion: based on previous investigations of similar complaints, the crack is most likely due to the collar being in contact with a chemical resulting in environmental stress cracking.All rt380 adult evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult 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: "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.".

• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12484520
• MDR Text Key: 272873716
• Report Number: 9611451-2021-01031
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728102
• UDI-Public: (01)09420012429728102(10)1325418(11)201006
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 2101325418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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