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

Model Number PT101

Device Problem No Audible Alarm (1019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo2 humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer.Results: customer reported that the audible alarm was not functioning properly.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The airvo 2 user manual states that the "airvo 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 test 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 distributor reported on behalf of a healthcare facility in (b)(6) that the speaker of a pt101 airvo 2 humidifier was not functioning properly.There was no patient involvement.

• 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: 10584400
• MDR Text Key: 208541548
• Report Number: 9611451-2020-00822
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429353
• UDI-Public: 01094200124293531021009161061119102121191021104253
• 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,health pr
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100916106
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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