MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are in the process to determine if the subject pt101 airvo 2 humidifier caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that a covid-19 patient with oxygen saturation (spo2) of around 85% had been using the pt101 airvo 2 humidifier for about 2-3 days when the patient experienced oxygen desaturation.It was further reported that the nurse was alerted to the desaturation by the patient's monitoring alarm.The nurse restarted the device and an error code e5 was displayed on the pt101 airvo 2 humidifier.The patient was then put on a non-rebreather mask.It was reported that the patient was later intubated.No further patient consequences were reported.

Manufacturer Narrative

(b)(4) method: the complaint pt101 airvo 2 humidifier was not returned to fisher & paykel healthcare for evaluation.Further information was retrieved from the healthcare facility.Our investigation is based on the information provided by the customer and our knowledge of the product.The healthcare facility reported that the patient was a covid-19 positive patient who was admitted into the emergency department with breathing difficulties, low spo2, diabetes and high blood pressure.The patient had hypoxia prior to set-up on the airvo 2 humidifier.On the day of the event, it was reported that the nurse was alerted to the oxygen desaturation by the patient's monitoring alarm and an error code e5 was displayed on the pt101 airvo 2 humidifier.The patient was then put on a nonrebreather mask.It was reported that the patient was later intubated.No further patient consequences were reported.Results: e5 error code may occur due to multiple factors including if the airvo 2 unit was dropped, shaken or exposed to water.When an e5 alarm is triggered, an audible alarm will sound and a visual alarm will display "fault e5" and "switch off the unit and then restart".Conclusion: without the complaint device, we are unable to determine the cause of the error code.However, the error code is likely due to subjecting the device to impact damage or exposure to water.As part of the investigation the patient's clinical condition was assessed, and it was noted that the patient was in critical condition prior to the event.The airvo 2 humidifier is designed to provide humidification therapy to spontaneously breathing patients who are not dependent on mechanical respiratory support.The airvo 2 user instruction specifies the following information: - 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 of their oxygen supply.- do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use.- never operate the unit if: - it has been dropped or damaged, - it has a damaged power cord or plug, - it has been dropped into water.

Event Description

A distributor reported on behalf of a healthcare facility in indonesia that a covid-19 patient with oxygen saturation (spo2) of around 85% had been using the pt101 airvo 2 humidifier for about 2-3 days when the patient experienced further oxygen desaturation.It was further reported that the nurse was alerted to the desaturation by the patient's monitoring alarm and an error code e5 was displayed on the pt101 airvo 2 humidifier.The patient was then put on a nonrebreather mask.It was reported that the patient was later intubated.No further patient consequences were reported.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 12285817
• MDR Text Key: 265346023
• Report Number: 9611451-2021-00873
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2101308776(11)200925
• 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,Followup
• Report Date: 07/08/2021

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: 2101308776
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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