MAUDE Adverse Event Report: MYAIRVO HUMIDIFIER

Model Number PT100

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient who was on the pt100 myairvo humidifier, deteriorated and was admitted into the intensive care unit (icu) with a chest infection.It was further reported by the customer there was no malfunction with the myairvo humidifier.No further patient consequences were reported.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a patient who was on the pt100 myairvo humidifier, deteriorated and was admitted into the intensive care unit (icu) with a chest infection.It was further reported by the customer there was no malfunction with the myairvo humidifier.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint pt100 myairvo 2 humidifier was not returned to fisher & paykel healthcare (f&p) in new zealand.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that a patient who was on the myairvo 2 humidifier, deteriorated and was admitted into the intensive care unit (icu) with a chest infection.It was further reported by the customer that there was no malfunction with the myairvo 2 humidifier.The biomedical engineer of the healthcare facility performance tested the myairvo 2 and confirmed that the device functioned as intended.Conclusion: we are unable to determine the cause of the reported event.However, based on the information provided by the customer, the subject myairvo 2 humidifier did not cause or contribute to the event as there was no fault found with the subject device.The myairvo 2 humidifier user manual states: "myairvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases." "the unit is not intended for life support." "appropriate patient monitoring must be used at all times." "ensure an air filter is fitted when operating your unit." the myairvo 2 humidifier user manual provides instructions for cleaning and maintenance including daily and weekly cleaning, followed by schedule for changing accessories to avoid risk of infection.

• Brand Name: MYAIRVO HUMIDIFIER
• Type of Device: MYAIRVO HUMIDIFIER
• MDR Report Key: 12375695
• MDR Text Key: 268426268
• Report Number: 9611451-2021-00997
• Device Sequence Number: 1
• Product Code: BTT
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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