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

Model Number PT101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Distress (2329)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received three airvo units with the following serial numbers: (b)(4) however, no clarification on which airvo linked to which incident.All three units were investigated and no fault were found with any of the returned units.We tried to request further information from the hospital to explain how the patient was "severely distressed".We did not receive any clarification from the hospital, however they did tell us that the "patient was moved to icu and recovered when the high flow was on again" method: the complaint airvo humidifier was received by fisher & paykel healthcare (f&p).The airvo was visually inspected and mechanically evaluated.The unit was disconnected from the power supply and reconnected again within 120 seconds.Results: the auditory alarm sounded continuously for 120 seconds and the unit automatically restarted when the power was reconnected.Conclusion: no fault was found with the complaint airvo unit and it functioned as intended.It was reported by the hospital that the power generator failed which led to the airvo unit turning off.Airvo is only designed to work with power and cannot operate if that power is removed.If the power is disconnected from the airvo it will alarm for at least 120 seconds to alert the user/caregiver.The airvo visual/auditory warning alarms and fault alarms meet the medium priority requirements as defined in iec 60601-1-8, the international standard comprising general requirements for basic safety and essential performance for medical electrical equipment and medical electrical systems.The hospital also reported that the patient had major health complications at the time of the incident, which may have caused or contributed to the adverse event; "down syndrome with pneumonia".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: during power outage, the auditory alarm will sound for at least 120 seconds.If power is reconnected in this time, the unit will automatically restart, unless the "audio pause" button has been pressed.Appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that a patient was connected to a pt101 airvo humidifier and receiving nasal high flow therapy.A power outage occurred due to some failure with the backup generator.It was further reported that the patient was severely distressed following this incident.We were also informed that the patient had down syndrome with pneumonia.The patient was moved to icu and recovered when the high flow was on again and no further patient consequences were reported.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7741713
• MDR Text Key: 115763594
• Report Number: 9611451-2018-00653
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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