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

Model Number PT100

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported that the audible alarm on their pt100 myairvo humidifier was not working.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint myairvo humidifier was returned to fisher & paykel healthcare in (b)(4) and was visually inspected and electrically tested.Results: during testing the airvo functioned normally.The visual alerts were operating, however no audible alarm was heard.The fault was traced to a faulty speaker and electrical resistance testing showed that the speaker's resistance was open circuit.A lot check revealed no other complaints of this nature for lot number 141119.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 adjusted the process and taken steps to ensure that each speaker is checked following the gluing process and that any found faulty are discarded.The myairvo 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.".

• Brand Name: MYAIRVO HUMIDIFIER
• Type of Device: MYAIRVO 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: 4920392
• MDR Text Key: 6027192
• Report Number: 9611451-2015-00315
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 141119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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