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

Model Number MR850

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Pneumonia (2011)

Event Date 08/16/2014

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that a pediatric home patient developed pneumonia while using an mr850 respiratory humidifier with an rt114 breathing circuit and a respironics trilogy ventilator.The mother of the patient reported excessive condensation in the breathing circuit, but no alarms from the mr850.The healthcare facility further reported that they replaced the humidifier, tested it and put it back into service with a different customer, where it operated with no issues.

Manufacturer Narrative

(b)(4).The complaint mr850 humidifier was not returned to fisher & paykel healthcare (fph).It was retrieved by the healthcare facility and tested.No fault was found with it so it was put back into service.Our records also indicate that the subject mr850 was returned to the service centre at our us facility for a service in december 2013.The mr850 was tested as per the mr850 product technical manual and passed all performance tests at the time, and was then returned to the customer.A lot check revealed no other complaints of this nature for lot number 100615.With regard to the patient contracting pneumonia, please note that : the mr850 humidification system consists of the mr850 heater base, mr290 humidification chamber and a breathing circuit which is connected to a port on the chamber dome.In order to humidify the breathing gas the patient receives, gas from the ventilator is passed over the heated fluid in the mr290 humidification chamber and picks up water vapour.The water vapour is then transported to the patient via the breathing circuit and interface.This heated passover humidification system ensures that only humidified gas reaches the patient.All mr290 chambers have plastic port caps that prevent ingress of dust or contaminants; water in the humidification chamber is heated to up to 80 degrees celsius; a temperature that does not support pathogenic microorganisms; humidity in the form of water vapour does not transport microorganisms.Tested and put back into service.

• 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: 4157832
• MDR Text Key: 19967272
• Report Number: 9611451-2014-00805
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2014

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: 100615
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2010
• 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: RESPIRONICS TRILOGY VENTILATOR; FISHER & PAYKEL HEALTHCARE RT114 BREATHING CIRCUIT