MAUDE Adverse Event Report: AIRVO2 HUMIDIFIER

Model Number	PT101
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint pt101 airvo 2 humidifier was not yet returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer had stated that the audible alarm sound was not working.Previous investigation 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.Conclusion: as part of our ongoing product improvement initiatives, we have implemented a soak test for 100% testing of the speaker harness on the airvo production line, which identifies and discards any faulty speakers prior to assembly into the airvo.Additionally, a new speaker unit has more recently been sourced from a different supplier.The subject airvo was manufactured prior to implementation of these measures.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 or Problem Description
A distributor in (b)(6) reported that the audible alarm of an airvo 2 humidifier was not working.There was no patient involvement.

• Brand Name: AIRVO2 HUMIDIFIER
• Common Device Name: AIRVO2 HUMIDIFIER
• MDR Report Key: 9851557
• Report Number: 9611451-2020-00290
• Device Sequence Number: 3331704
• Product Code: BTT
• UDI-Device Identifier: 09420012425218
• UDI-Public: (01)09420012425218
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K131895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100007443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/19/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2015
• 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