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

Model Number RT380

Device Problems Break (1069); Crack (1135); Gas/Air Leak (2946)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative, that the collar of a rt380 adult dual heated evaqua2 breathing circuit was damaged during use.There was no reported patient consequence.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the collar of a rt380 adult dual heated evaqua2 breathing circuit was damaged during use.There was no reported patient consequence.

Manufacturer Narrative

Ps377223, 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 rt380 adult dual heated evaqua2 breathing circuit confirmed that the patient end evaqua2 collar was cracked.It was also noted that a white residue was found inside the y-piece.Further analysis of the returned complaint device revealed that the fractured 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: the observed crack is most likely due to the collar being in contact with a chemical resulting in environmental stress cracking.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 circuits would have met the required specifications at the time of production.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit states: "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: 12451638
• MDR Text Key: 273191054
• Report Number: 9611451-2021-01009
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2021
• 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: HUMIDIFIER: MR850GJU; HUMIDIFIER: MR850GJU; SAVINA VENTILATOR; SAVINA VENTILATOR