MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem No Audible Alarm (1019)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that the audio alarm of a pt101 airvo 2 humidifier was not working.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) for evaluation where it was inspected by a trained f&p technician.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the audible alarm did not function and electrical resistance testing has shown the speaker's resistance to be open circuit.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The airvo 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 the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the audio alarm of a pt101 airvo 2 humidifier was not working.There was no reported patient consequence.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 10687819
• MDR Text Key: 213478667
• Report Number: 9611451-2020-00892
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100549369(11)180807
• 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: 09/16/2020

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: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100549369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2018
• 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