MAUDE Adverse Event Report: HEATED BREATHING TUBE; AIRVO HEATED BREATHING TUBE

Model Number 900PT561

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigations.We will provide a follow up report upon completion of our investigations.

Event Description

A healthcare facility reported via the fda maude database of an incident where the patient was setup with a non-f&p nebulizing device, a 900pt561 airvo heated breathing tube and a nasal cannula.It was noted that the breathing tube became disconnected from the non-f&p nebulizing device during use.The disconnection was identified when the patient's condition worsened.The patient later deceased.No further information regarding the reported event is available.

Manufacturer Narrative

(b)(4).Method: the complaint 900pt561 airvo heated breathing tube was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Result: the customer reported an incident where the patient was setup with a non-f&p nebulizing device, a 900pt561 airvo heated breathing tube and a nasal cannula.It was noted that the breathing tube became disconnected from the non-f&p nebulizing device during use.The disconnection was identified when the patient's condition worsened.The patient later deceased.No further information regarding the reported event is available.Conclusion: based on the information provided by the customer, it is likely that the reported disconnection was caused by the incorrect use of a 3rd party nebulizer adaptor between the 900pt561 airvo heated breathing tube and the nasal cannula.The 900pt561 airvo heated breathing tube is not designed for use with 3rd party nebulizer adaptors.The user instructions that accompany the 900pt561 airvo heated breathing tube states the following: this product is not intended for use with any medication.Warning: use of non-approved accessory could impair performance or compromise safety.The user instructions that accompany the airvo 2 humidifer also states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and that "the unit is not intended for life support.".

Event Description

A healthcare facility reported via the fda maude database of an incident where the patient was setup with a non-f&p nebulizing device, a 900pt561 airvo heated breathing tube and a nasal cannula.It was noted that the breathing tube became disconnected from the non-f&p nebulizing device during use.The disconnection was identified when the patient's condition worsened.The patient later deceased.No further information regarding the reported event is available.

• Brand Name: HEATED BREATHING TUBE
• Type of Device: AIRVO HEATED BREATHING TUBE
• MDR Report Key: 12444020
• MDR Text Key: 270474999
• Report Number: 9611451-2021-01037
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death