MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Loss of Power (1475)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The pt101 airvo2 humidifier 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 "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply".The airvo2 user manual also states following warnings: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.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.If either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.The airvo2 user manual states that "when the unit has been disconnected from the mains/utility power socket the auditory alarm will sound for at least 120 seconds.If power is reconnected in this time, the unit will automatically restart".

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient deteriorated following a power outage at the hospital, while using the pt101 airvo2 humidifier.There was no reported device malfunction.No further patient consequences were reported.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11898813
• MDR Text Key: 253117843
• Report Number: 9611451-2021-00602
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100521189(11)180703
• 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
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100521189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• 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
• Patient Outcome(s): Other