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 Type  malfunction  

Event Description

A biomedical engineer at a healthcare facility in new jersey reported that a home patient sustained a burn to their throat while using an mr850 respiratory humidifier with an rt114 breathing circuit and a heated trach collar.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 humidifier was returned to the fisher & paykel healthcare (fph) service centre at our us facility for inspection.The mr850 was visually inspected and performance tested as per the mr850 product technical manual.Our analysis is accordingly based on the inspection results, and additional information provided by the biomed.Results: the returned mr850 was inspected externally and no issues were noted.The subject mr850 humidifier passed the performance checks.The humidifier was also tested for temperature setting and alarms and was found to be operating correctly.A lot check revealed no other complaints of this nature for lot number 130530.Conclusion: no fault was found with the subject mr850 as it passed the visual inspections and performance checks.The mr850 was returned to the hospital after the inspection.The nurse who was present at the time of the incident informed us that they left the room for about 10 minutes and when they returned the child had a fever of "over 101 degrees" fahrenheit.The nurse also stated that the mr850 did not alarm and was displaying a temperature reading of 36.1 degrees celsius.No further details were provided about the alleged burn.The mr850 appears to have been operating correctly at the time of the incident.The temperature displayed at the time of the incident was within the expected range and below body temperature.It is therefore reasonable to assume that the breathing gas as heated by the rt114 circuit would not have been hot enough to burn the patient's throat.We were unable to determine definitively the root cause of the reported burn to the patient's throat.It must be noted that the subject mr850 was set up with a non-fph interface, a heated trach collar.Fph only recommends the use of fph accessories with our humidifiers.The warning contained in our user instructions and printed on fph humidifiers states the following: the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance and compromise safety.Tested and returned to the customer.

• 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: 4146226
• MDR Text Key: 4930656
• Report Number: 9611451-2014-00798
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/08/2014

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
• Device Lot Number: 130530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2013
• 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
• Treatment: FISHER & PAYKEL HEALTHCARE RT114 BREATHING CIRCUIT