MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint device was not available for investigation.Therefore, our investigation is based on the information provided by the customer and our knowledge of the product.Results: it was reported that the clinician turned off the gas flow to the humidifier and accidentally left the system with no flow going through the humidification chamber.Conclusion: based on the information provided the cause of the problem reported by the customer is due to incorrect set up and use of the mr850 respiratory humidification system.As noted above the customer acknowledged that the reported incident was due to "operator error".Since the reported incident a fph representative has been in contact with the customer to inform them of the correct set up and use of the mr850 respiratory humidification system.

Event Description

A healthcare facility in (b)(6), reported an incident to a fisher & paykel healthcare (fph) representative where a patient was receiving heliox and supplemental oxygen in a set up which included an optiflow junior interface, rt330 optiflow breathing circuit and an mr850 respiratory humidifier.It was further reported that at some point during the night the staff turned off the gas flow to the mr850 respiratory humidifier.They further reported that the humidification chamber on the mr850 deformed.The customer further informed us that the reported incident was due to an "operator error".No patient consequence was reported.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• 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: 5224360
• MDR Text Key: 31412400
• Report Number: 9611451-2015-00471
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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