MAUDE Adverse Event Report: MYAIRVO 2 HUMIDIFIER

Model Number	PT100
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint pt100 myairvo 2 humidifier was not received at fisher & paykel healthcare (f&p) in (b)(4) for evaluation.The customer has stated that the myairvo 2 unit did not have an audible alarm, previous investigations into audio alarm failures have identified that the problem is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to be open circuit.As part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The myairvo 2 humidifier user manual states that the "myairvo 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." 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 or Problem Description
A distributor in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative that the audible alarm of a pt100 myairvo 2 humidifier was not functioning.There was no reported patient involvement.

• Brand Name: MYAIRVO 2 HUMIDIFIER
• Common Device Name: MYAIRVO 2 HUMIDIFIER
• MDR Report Key: 12346079
• Report Number: 9611451-2021-00972
• Device Sequence Number: 11715238
• Product Code: BTT
• UDI-Device Identifier: 09420012422248
• UDI-Public: (01)09420012422248(10)2100077560(11)160830
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 2100077560
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1