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

Model Number PT101

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/02/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining more information from the customer and to retrieve the subject pt101 airvo 2 humidifier for assessment to determine if fisher &paykel healthcare's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient with interstitial pneumonia was found deceased while on a pt101 airvo 2 humidifier.The hospital reported that the nasal cannula was found disconnected to the breathing circuit.It was also reported that biological monitoring was not in place for the patient.

Event Description

A hospital in japan reported via a fisher & paykel healthcare (f&p) field representative that a patient with interstitial pneumonia was found deceased while on a pt101 airvo 2 humidifier.The hospital reported that the nasal cannula was found disconnected to the breathing circuit.It was also reported that biological monitoring was not in place for the patient.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo 2 humidifier was received at fisher & paykel healthcare (f&p) regional office in japan and performance tested.The log report retrieved from the complaint airvo 2 device was reviewed by an f&p investigation engineer in nz.The complaint airvo 2 device was returned to service by the customer.Despite several attempts, we were unable to obtain further information from the customer regarding the sequence of events and the set up of the devices.The opt944 optiflow cannula and 900pt561 heated breathing tube were not returned to f&p for evaluation.Results: the complaint pt101 was performance tested and found to be functioning as expected.The review of the log report also revealed that the device was functioning as expected.Conclusion: we are unable to determine what caused the reported event as the complaint airvo 2 device was investigated and no fault was found.However, the customer did report that the event was not due to a malfunction of f&p devices, but most likely due to user error & lack of staff training.The f&p field representative visited the hospital and conducted product training with the staff.As such, there is no indication that any f&p products caused or contributed to the reported event.The pt101 airvo 2 humidifier 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 "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." additionally, the user manual also warns the user: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.The setup instructions in the user instructions which accompany the opt944 nasal cannula include the following steps: - ensure head strap clip is attached, to prevent cannula from being pulled out of the nares.- cannula can become unattached if not used with the head strap clip.- attach tubing clip to clothing/bedding to prevent cannula from pulling off face.Additionally, the user instruction also warns the user: - appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.

• 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: 9679735
• MDR Text Key: 178095284
• Report Number: 9611451-2020-00122
• 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: 01/08/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900PT561 BREATHING TUBE; F&P 900PT561 BREATHING TUBE; F&P OPT944 NASAL CANNULA; F&P OPT944 NASAL CANNULA; F&P 900PT561 BREATHING TUBE; F&P OPT944 NASAL CANNULA
• Patient Outcome(s): Death