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

Model Number PT101

Device Problems Loss of Power (1475); No Apparent Adverse Event (3189)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to obtain the subject complaint device for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A healthcare facility in (b)(6) reported via a distributor to a fisher & paykel healthcare (f&p) field representative that a patient was connected to an airvo 2 humidifier when allegedly the unit turned off.It was further reported that the patient's peripheral arterial oxygen saturation (spo2) levels decreased from 90% to 82%.F&p understands that the patient received an "emergency treatment".No further patient consequence was reported.The healthcare facility further reported that the airvo 2 humidifier turned off again another day with no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was performance tested.Result: performance test of the returned unit revealed that the unit passed all tests and was within specification.No fault was found with the returned unit.Conclusion: we are unable to determine what caused the reported event as the device was found to be operating within specification.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." additionally, the airvo user manual instructs the user to "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 china reported via a distributor to a fisher & paykel healthcare (f&p) field representative that a patient was connected to an airvo 2 humidifier when allegedly the the unit turned off.It was further reported that the patient's peripheral arterial oxygen saturation (spo2) levels decreased from 90% to 82%.F&p understands that the patient received an "emergency treatment".No further patient consequence was reported.The healthcare facility further reported that the airvo 2 humidifier turned off again another day with no reported patient consequence.

• 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
• MDR Report Key: 7954571
• MDR Text Key: 123376912
• Report Number: 9611451-2018-00868
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 140804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900MR501 HEATED BREATHING CIRCUIT; F&P 900MR501 HEATED BREATHING CIRCUIT; F&P MR290 HUMIDIFICATION CHAMBER; F&P MR290 HUMIDIFICATION CHAMBER; F&P OPT318 NASAL CANNULA; F&P OPT318 NASAL CANNULA