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

Model Number PT101

Device Problem Detachment Of Device Component (1104)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that on two occasions, while a patient was using the pt101 airvo humidifier, the airvo became unplugged "at the wall".No patient consequence was reported for the first incident.In the second incident the patient became desaturated, with an spo2 of 69%.Staff had reportedly moved the airvo, causing it to become unplugged from the mains supply.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).The airvo is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.The complaint airvo humidifier was not returned to fisher & paykel healthcare (fph) (b)(4) for evaluation, but has been retained by the hospital.Our investigation is based on the information supplied by the hospital.There was no alleged damage or defect with the airvo.Rather, the hospital was dissatisfied because disconnection of power supply to the airvo meant loss of therapy for the patient.If the power is disconnected from the airvo it will alarm for at least 120 seconds to alert the user/caregiver.The airvo 2 user manual instructs the user to "use continual pulse oximetry for patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also states: - the airvo 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.As part of our ongoing improvement initiatives fisher & paykel healthcare is currently developing a ups for the airvo.The ups will be available as an accessory for the airvo.Use of the ups will enable the airvo to continue operating in the event of a disconnection from electrical power.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3786505
• MDR Text Key: 15364007
• Report Number: 9611451-2014-00391
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL OPTIFLOW TRACHEOSTOMY INTERFACE