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

Model Number PT101

Device Problems Device Alarm System (1012); Infusion or Flow Problem (2964); Protective Measures Problem (3015)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject pt101 airvo 2 humidifier.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that a pt101 airvo 2 humidifier displayed an e85 error code.It was further reported that the patient desaturated and was placed on a ventilator.There were no further reported patient consequences.

Manufacturer Narrative

(b)(4).Method: several attempts to request further information from the customer and to retrieve the subject device for investigation were made, however no response was provided.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a pt101 airvo 2 humidifier displayed an e85 error code.It was further reported that the patient desaturated and was placed on a ventilator.An e85 error code could occur due to a mains voltage supply issue.When an e85 alarm is triggered, an audible alarm will sound, and a visual alarm will display "fault e85" and "switch off the unit and then restart".Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.The airvo 2 user manual states that "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases." the user manual also warns the user: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.- use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.

Event Description

A healthcare facility in virginia reported that a pt101 airvo 2 humidifier displayed an e85 error code.It was further reported that the patient desaturated and was placed on a ventilator.There were no further reported patient consequences.

• 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
• 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: 12725735
• MDR Text Key: 279241512
• Report Number: 9611451-2021-01225
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2100233197(11)170606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2100233197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/31/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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; Required Intervention