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

Model Number RT380

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation.This device was visually inspected.Results: the inspiratory limb was returned with the elbow and the patient end connector loose.Conclusion: we were unable to determine conclusively the cause of the reported event.However, it is possible that the circuit was cleaned and reused which could lead to the reported event.Rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.If any faults are detected the whole batch is placed on hold for investigation.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Set appropriate ventilator alarms.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the connector of a rt380 adult dual heated evaqua2 breathing circuit was found loose before patient use.There was no patient involvement.

• 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, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 8895829
• MDR Text Key: 175653055
• Report Number: 9611451-2019-00778
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• 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: 2100720534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• 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