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

Model Number MR850

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident that is the subject of this complaint occurred on (b)(6) this year.Fisher & paykel healthcare (fph) was only notified of the complaint on (b)(6) 2015.As (b)(6) months had elapsed it has not been possible to obtain any information about the alleged incident, nor were we able to retrieve the complaint devices (humidifier and cannula) for evaluation.Two attempts were made to obtain further information from the hospital but no response was received.We have not received any other complaint for this type of injury for the mr850 humidifier.The mr850 is equipped with several safety features that limit the risk of thermal injury.In the event of a failure the unit will shut down in a safe state and warn the user that a fault has occurred.It does this by monitoring the correct operation of its critical circuits.If a fault is detected it will try to report this by giving an error code and alarming visually and audibly.The mr850 complies with (b)(4): "respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems." this standard specifies safety requirements to prevent the risk of thermal injury, including maximum enthalpy limits for humidified gas delivered to patients through respiratory humidification systems.The mr850 also complies with the medical devices directive 93/42 eec, annex i "essential requirements".

Event Description

A hospital in (b)(6) reported to the fda that a patient sustained a burn to their ear while using an mr850 respiratory humidifier with an opt314 optiflow junior cannula.

• 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 ; 9194534000
• MDR Report Key: 5213984
• MDR Text Key: 31115910
• Report Number: 9611451-2015-00470
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2015

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: MR850
• Device Catalogue Number: MR850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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