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

Model Number PT101

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo humidifier is expected at our fisher & paykel healthcare regional office in the (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the audible alarm of an airvo 2 humidifier was not working.This was found before patient use.

Manufacturer Narrative

(b)(4) method: the complaint airvo humidifier was received at our fisher & paykel healthcare (fph) regional office in the uk where it was inspected by a trained fph technician.The device was performance tested and the audible alarm function was checked.The device was reportedly then sent to our new zealand office but it has not been received.Results: during testing at our regional office it was found that the visual alerts on the complaint airvo were operating, however no audible alarm was heard.Previous investigations into this type of failure have identified that the problem is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to be open circuit.A lot check revealed one other complaint of this nature for lot number 130701.Conclusion: the supplier of the speaker unit was notified and they have carried out an investigation.The problem has been traced to an issue with the gluing process.The supplier has taken steps to ensure that each speaker is checked following the gluing process and any found faulty are discarded.Additional checks have also been implemented during production at our facility to ensure the speaker is working at the time of manufacture of the airvo.The subject airvo was manufactured before implementation of these measures.The airvo 2 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." the user manual also contains instructions on how to check the alarm system functionality and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".

Event Description

A hospital in (b)(6) reported that the audible alarm of an airvo 2 humidifier was not working.This was found before patient use.

• 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: 5321111
• MDR Text Key: 34199547
• Report Number: 9611451-2015-00557
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

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: 130701003667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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