MAUDE Adverse Event Report: ADULT VENTILATOR DUAL HEATED CIRCUIT KIT; BZE

Model Number 950A81

Device Problems Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 950a81 adult ventilator dual heated circuit kit is not sold in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product is k122432.The complaint 950a81 adult ventilator dual heated circuit kit is currently en route to fisher & paykel healthcare (b)(6) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that two 950a81 adult ventilator dual heated circuit kits failed the leak test during device setup.There was no patient involvement.

Manufacturer Narrative

(b)(4).The 950a81 adult ventilator dual heated circuit kit is not sold in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product is k122432.Method: one of the two complaint 950a81 adult ventilator dual heated circuit kits was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and pressure tested.Results: visual inspection of the complaint device revealed no signs of damage.The pressure test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the 950a81 breathing circuits to fail the leak test, as reported by the customer, as no fault was found with the returned device.All 950a81 adult ventilator dual heated breathing circuits are 100% leak tested during production, and those that fail are rejected.The subject 950a81 breathing circuit would have met the required specifications at the time of production.The user instructions which accompany the 950a81 adult ventilator dual heated circuit kit illustrate state the following: "perform a pressure and leak test on the breathing system before connecting to a patient." "check all connections are tight before use." the user instructions also warn the user: "set appropriate ventilator or flow source alarms to monitor therapy delivery.".

Event Description

A healthcare facility in australia reported, via a fisher & paykel healthcare (f&p) field representative, that two 950a81 adult ventilator dual heated circuit kits failed the leak test during device setup.There was no patient involvement.

• Brand Name: ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
• Type of Device: BZE
• MDR Report Key: 11381116
• MDR Text Key: 242756191
• Report Number: 9611451-2021-00219
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: 950A81
• Device Catalogue Number: 950A81
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• 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