MAUDE Adverse Event Report: AIRVO2 HUMIDIFIER

Model Number PT101

Device Problem Low Audible Alarm (1016)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We have requested the return of the complaint pt101 airvo 2 humidifier for 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 pt101 airvo 2 humidifier "alarm was low" during patient use.It was also reported that the patient stats dropped from 94-88% spo2 levels to 85% spo2 levels and the patient was moved to cpap therapy.No further patient consequences were reported.

Manufacturer Narrative

Ps(b)(4).Method: the complaint pt101 airvo 2 humidifier was not received at fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the pt101 airvo 2 humidifier "alarm was low" during patient use.It was also reported that the patient stats dropped from 94-88% spo2 levels to 85% spo2 levels and the patient was moved to cpap therapy.It was noted that the patient medical history included "acute respiratory failure due to covid-19." conclusion: as we have not received the complaint device, we are unable to determine the cause of the failure mode in this instance.As part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The airvo 2 humidifier user manual 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." the user manual warns the user: - prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section.The alarm system functionality check instructs the user on how to check the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".

Event Description

A healthcare facility in louisiania reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier "alarm was low" during patient use.It was also reported that the patient stats dropped from 94-88% spo2 levels to 85% spo2 levels and the patient was moved to cpap therapy.No further patient consequences were reported.

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 HUMIDIFIER
• MDR Report Key: 11174675
• MDR Text Key: 245162507
• Report Number: 9611451-2021-00028
• Device Sequence Number: 1
• Product Code: BTT
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101043245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1