MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO 2 HUMIDIFIER

Model Number PT100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Ventilator Dependent (2395)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint device is currently at fisher and paykel healthcare in (b)(4) for evaluation to determine if it had a malfunction which might have lead to the reported event.We have followed up with the customer multiple times for more information.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported via a fisher and paykel healthcare field representative that an "infant's condition worsened" after being transferred from the intensive care unit to a myairvo in a rehabilitation unit.The patient was then invasively ventilated and is now stable.

Event Description

A distributor in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that an "infant's condition worsened" after being transferred from the intensive care unit to a myairvo in a rehabilitation unit.The patient was then invasively ventilated and is now stable.

Manufacturer Narrative

(b)(4).Method: the complaint myairvo humidifier and a 900pt531 fph airvo pediatric heated breathing tube were received at fisher & paykel healthcare (fph) (b)(4) and were visually inspected and performance tested.An opt316 fph optiflow junior nasal cannula was also received and visually inspected.Multiple attempts were made to obtain further information from the customer regarding the incident, however no response was received.Results: the subject airvo and the 900pt531 heated breathing tube showed no signs of damage upon visual inspection.Visual inspection of the returned opt316 nasal cannula revealed the nasal prongs to be stained yellow, however no blockages were present.The 900pt531 heated breathing tube was connected to the airvo for performance testing and both were found to function within specification with no faults or defects.The airvo log showed no faults for the lifetime of the device.Additionally, the airvo log showed no usage time from the date of the incident.We note that the airvo log will record time used on any given day, provided that the airvo has been used for a minimum of 6 minutes.Conclusion: no faults were found with any of the returned devices and all were found to be operating within specification.The customer confirmed that the patient's condition stabilized once placed on mechanical ventilation.This suggests that the patient's worsened condition was not due to any malfunction of the airvo system, but rather may have been due to premature removal from mechanical ventilation.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." it also states "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.".

• Brand Name: MYAIRVO 2 HUMIDIFIER
• Type of Device: MYAIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7136878
• MDR Text Key: 95451221
• Report Number: 9611451-2017-01222
• 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: 11/21/2017

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: Other Health Care Professional
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 2100078910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 01/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 900PT531 FPH AIRVO PEDIATRIC HEATED BREATHING TUBE; OPT316 FPH OPTIFLOW JR. NASAL CANNULA
• Patient Outcome(s): Hospitalization