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

Model Number PT101

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo humidifier was returned to our fisher & paykel healthcare regional office in (b)(4) for evaluation.The device was performance tested and passed all functional tests.The hospital had stated that the airvo flow rate dropped without them adjusting the flow themselves.Based on the description of events it is most likely that the flow had become restricted due to a blockage in the breathing system.The most likely cause for this is kinking of the prongs.If the flow rate drops below a certain limit the airvo will alarm with a "cannot reach target flow" audio and visual alarm.The user then has the choice to accept the lower flow rate or address the problem in order to restore the correct flow rate.No fault was found with the subject airvo.We have concluded that the reported incident was not caused by a malfunction of the airvo itself but rather by a blockage in the flow delivery system, most likely caused by kinking of the prongs.The airvo 2 user manual provides the folllowing warnings: - do not block the flow of air through the unit and breathing tube.The unit cannot reach the target flow setting: - check the heated breathing tube or patient interface for blockage.The manual also 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.".

Event Description

A hospital in (b)(6) reported that a child with pneumonia was connected to an airvo 2 humidifier, with a flow of 12 l/min and 45% o2 after four days of therapy, it was observed that the child's saturation values had decreased to less than 80%.It was found that the airvo was only showing a flow of 2 l/min on the display, even though the set flow was still 12 l/min.The child was removed from the airvo and put on standard o2 therapy.The child then recovered quickly.

• 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: 5103035
• MDR Text Key: 26912306
• Report Number: 9611451-2015-00419
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/28/2015

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: 150407012771
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 30 MO