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

Model Number 950A81

Device Problems Gas/Air Leak (2946); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 950a81 adult ventilator dual heated circuit kit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k122432.We are currently in the process of investigation.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 a 950a81 adult ventilator dual heated circuit kit had failed the leakage test during setup.There was no patient involvement.

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that a 950a81 adult ventilator dual heated circuit kit had failed the leakage test that was conducted during setup, as outlined in the user instructions that accompany the 950a81.There was no patient involvement.

Manufacturer Narrative

(b)(4).The 950a81 adult ventilator dual heated circuit kit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k122432.Method: the complaint 950a81 adult ventilator dual heated circuit kit was received at fisher & paykel healthcare in new zealand where it was visually inspected and leak tested.Results: visual inspection found no sign of damage on the complaint device.Leak test was performed and it was found that the breathing circuit had gas leak around the t seal ring of the inspiratory connector.Conclusion: we are unable to determine the cause of the reported failure mode at this stage.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 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: "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.".

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that a 950a81 adult ventilator dual heated circuit kit had failed the leakage test that was conducted during setup, as outlined in the user instructions that accompany the 950a81.There was no patient involvement.

Manufacturer Narrative

(b)(4).Additional information: a second complaint device was received on the (b2019.Section g4 has been updated.Section h10 quantity of devices has been updated to two units).The 950a81 adult ventilator dual heated circuit kit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k122432.Method: the two complaint 950a81 adult ventilator dual heated circuit kit was received at fisher & paykel healthcare in new zealand where they were visually inspected and leak tested.Results: visual inspection found no sign of damage on the complaint devices.Leak test was performed and it was found that both of the breathing circuits had gas leak around the t seal ring of the inspiratory connector.Conclusion: we are unable to determine the cause of the reported failure mode at this stage.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 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: "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.".

• Brand Name: ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8900049
• MDR Text Key: 159518579
• Report Number: 9611451-2019-00783
• 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,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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: 2100764751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1