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

Model Number 950A81

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The (b)(4) 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.The complaint (b)(4)adult ventilator dual heated circuit kit is currently en route to fph in (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 a 950a81 adult ventilator dual heated circuit kit had failed the ventilator tightness 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 ventilator tightness test during setup.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.The complaint 950a81 adult ventilator dual heated circuit kit was not returned to fisher & paykel healthcare in new zealand for evaluation.Our investigation is therefore based on the information provided by the customer and our knowledge of the product.The hospital reported that the ventilator failed the tightness test during setup, and "through process of elimination" the fault was determined to be with the breathing circuit connected to the humidifier.It was also reported that the water bag spike was not connected to the water bag, and that the humidifier was "working fine." without the complaint device, we are unable to determine the cause of the reported failing of the tightness check and we are unable to confirm if there was a leak present in the 950a81 breathing circuit.The most likely cause of the reported tightness test failure is that the water bag spike was not connected to the water bag, as reported by the healthcare facility.The spike holder is designed to house the bag spike during transportation to protect the unit and packaging from damage.While the spike holder may form a tight seal, it is not the intent of the holder to create a leak-proof seal.All 950a81 adult ventilator dual heated breathing circuits are visually inspected and pressure 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 pictorially the proper setup of the breathing circuit, including the removal of the water bag spike from the holder and the connection of the spike to the water bag.They also 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: 8656996
• MDR Text Key: 146655537
• Report Number: 9611451-2019-00545
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1