MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO2 HUMIDIFIER

Model Number PT100

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint myairvo humidifier had not been received at fisher & paykel healthcare for evaluation.The customer had stated that he would return the device himself but to date it has not been received.A lot check revealed one other complaint of this nature for lot number 130320.Previous investigations into faulty speakers have shown that the problem is usually the result of an open circuit in the speaker.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.The subject myairvo was manufactured before the supplier implemented these additional checks.The myairvo 2 user manual states that the "myairvo 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 a myairvo 2 humidifier was not working.There was no patient consequence.

• Brand Name: MYAIRVO2 HUMIDIFIER
• Type of Device: MYAIRVO2 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: 5170596
• MDR Text Key: 29324725
• Report Number: 9611451-2015-00446
• 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: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2015

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: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 130320001265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2013
• 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