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

Model Number RT380

Device Problems Component Missing (2306); Connection Problem (2900)

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

Event Date 06/18/2021

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 investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that a rt380 adult dual-heated evaqua2 breathing circuit did not have heater wires inside the expiratory limb.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in south korea that a rt380 adult dual-heated evaqua2 breathing circuit did not have heater wires inside the expiratory limb.There was no patient involvement.

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 thus based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the expiratory limp did not have a heater wire and heater wire plug.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All 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 subject breathing circuit would have met the requirements at the time of production.The user instructions that accompany the rt380 breathing circuit state the following: - check all connections are tight before use.- set appropriate ventilator alarms.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- do not reuse this product.Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 12201468
• MDR Text Key: 264945510
• Report Number: 9611451-2021-00852
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(1002101529841(11)210227
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2101529841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2021
• 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