MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) (b)(6) for evaluation.We are in the process of determining whether f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier was faulty.It was reported that the patient desaturated to 60% spo2 and became cyanotic.The patient was transferred to the intensive care unit and intubated.The patient has since fully recovered and has been discharged.A performance check was conducted by the hospital clinical engineer and the device passed all performance checks and was performing as intended.

Manufacturer Narrative

(b)(4).Method: the subject pt101 airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) for evaluation.The subject airvo 2 was visually inspected, performance tested and error log was reviewed.Results: review of the error log identified that the only errors that were present occurred during disinfection mode.Visual inspection and performance testing revealed no faults with the subject pt101 airvo 2 humidifier and the reported event was unable to be replicated.Conclusion: we are unable to determine what may have caused the event as there was no fault found with the subject pt101 airvo 2.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 also warns the user that 'appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.'.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier was faulty.It was reported that the patient desaturated to 60% spo2 and became cyanotic.The patient was transferred to the intensive care unit and intubated.The patient has since fully recovered and has been discharged.A performance check was conducted by the hospital clinical engineer and the hospital advised that the device passed all performance checks and was performing as intended.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 10912706
• MDR Text Key: 218657512
• Report Number: 9611451-2020-01056
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100253498(11)170703
• 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,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100253498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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
• Patient Age: 9 MO