MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

Model Number PT101

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo unit is currently en route to fisher & paykel healthcare for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a distributor that the myairvo humidifier unit had no audio alarm.There was no patient involvement.

Event Description

A healthcare facility in thailand reported via a distributor that the myairvo humidifier unit had no audio alarm.There was no patient involvement.

Manufacturer Narrative

Ps299450 method: the complaint airvo humidifier was not received for evaluation.Our investigation is based on the customer's description of events.The customer has stated that the airvo 2 unit did not have an audible alarm.Results: 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.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 the new speaker.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.".

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8262963
• MDR Text Key: 133937220
• Report Number: 9611451-2019-00051
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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: Lay User/Patient
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 151019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1