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

Model Number RT380

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in (b)(6) reported via a distributor to 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.

Manufacturer Narrative

Ps311243 method: (1) the complaint rt380 adult evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Our investigation is therefore based on the information and photo provided by the customer and our knowledge of the product.(2)the customer returned a sample rt380 adult evaqua2 breathing circuit identified as 190228 to f&p in new zealand for investigation.This device was visually inspected.Results: (1) the provided photos show large gaps between the connectors and the inspiratory tubing of the complaint device.(2) no fault was found with the inspiratory limb returned sample rt380 adult evaqua2 breathing circuit.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 healthcare facility in japan reported via a distributor to 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 LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8720773
• MDR Text Key: 149133481
• Report Number: 9611451-2019-00596
• Device Sequence Number: 1
• Product Code: BZE
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 2100651415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1