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

Model Number 900PT501

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We have requested further information with regards to the reported event.We will provide a follow up upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the 900pt501 airvo heated breathing tube disconnected from opt844 adult nasal cannula during patient use.It was further reported that the patient desaturated to 86% spo2 but recovered to 100% spo2 once the heated breathing tube was replaced.

Event Description

A healthcare facility in china reported via a fisher & paykel healthcare (f&p) field representative that the 900pt501 airvo heated breathing tube disconnected from opt844 adult nasal cannula during patient use.It was further reported that the patient desaturated to 86% spo2 but recovered to 100% spo2 once the heated breathing tube was replaced.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).The 900pt501 adult heated breathing tube (hbt) is used with the airvo humidifier to deliver warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Method: the complaint 900pt501 airvo heated breathing tube was not returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.Further information from the customer was requested, however no information was provided.Our investigation is thus based on the initial information provided by the customer and our knowledge of the product.Results: the customer reported that the 900pt501 airvo heated breathing tube disconnected from the opt844 adult nasal cannula during patient use.It was noted that the patient desaturated to 86% spo2 but recovered to 100% spo2 once the heated breathing tube was replaced.Conclusion: without the complaint device, it is not possible to conclusively determine what had caused the reported event.All 900pt501 circuits are tested for connectivity and electrical continuity during production and those that fail are rejected.The subject 900pt501 would have met the required specification at the time of production.In the event of a system leak, the airvo will produce a visual and auditory alarm and the airvo user manual instructs the caregiver to "check that the heated breathing tube is not damaged and that it is plugged in correctly." the airvo humidifier user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the airvo humidifier user manual also states that the "airvo 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.".

• Brand Name: HEATED BREATHING TUBE
• Type of Device: AIRVO HEATED BREATHING TUBE,
• MDR Report Key: 11033239
• MDR Text Key: 222666575
• Report Number: 9611451-2020-01162
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• 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: 11/20/2020

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: 900PT501
• Device Catalogue Number: 900PT501
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/19/2021
• 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
• Treatment: FISHER & PAYKEL (F&P) OPT844 ADULT NASAL CANNULA