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

Model Number PT101

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that a pt101 airvo 2 humidifier gave a blockage alarm and flow "seemed to stop".Hospital staff changed the interface and circuit over time but the issue did not resolve.The patient desaturated and staff removed the airvo and placed the patient on a re-breathe mask, whereupon patient saturations improved.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint airvo humidifier was received at our fisher & paykel healthcare service centre in (b)(4) and was visually inspected and performance tested in accordance with the airvo product technical manual.Our investigation is based on the inspection results and information provided by the customer.Result: visual inspection at our (b)(4) service centre revealed that the blockage alarm was caused by a displaced silicone flap on the blower outlet.The blower outlet has a non-return valve to prevent water ingress.The valve has two silicone flaps.The displaced flap was repositioned and the unit tested and functioned normally with no alarms.The subject airvo was returned to the hospital to be put back into service.Conclusion: the subject airvo correctly alarmed to alert the caregiver that there was something blocking flow.We can conclude that the blockage alarm was due to the displaced silicone flap in the non-return valve.Our user instructions that accompany the airvo humidifier state that "the airvo 2 is for the treatment of spontaneously breathing patients (adult and pediatric > 3 kg) who would benefit from receiving high flow warmed and humidified respiratory gases." they also state: "the unit is not intended for life support.".

• 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: 4212172
• MDR Text Key: 5151813
• Report Number: 9611451-2014-00835
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2014

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
• Device Lot Number: 140303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2014
• 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