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

Model Number MR850

Device Problems Moisture Damage (1405); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information to determine if fph's product caused or contributed to the event.Our investigation is in progress and we will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6), reported that a set up which involved a fisher & paykel healthcare (fph) mr850 respiratory humidifier, ltv1150 ventilator and pulmonetics/airlife breathing circuit was allegedly over heating and more than normal condensate was found in the breathing circuit.They further reported that the ventilation was disrupted and that the patient's heart rate and respiratory rate increased and a mild burn was noted on the circumference of the tracheostomy stoma.The patient's condition was reported to be stable and that nystatin lotion was used on the reported burn.

Manufacturer Narrative

(b)(4).The complaint mr850jhu respiratory humidifier was not returned to fisher & paykel healthcare for investigation.Our analysis is accordingly based on the additional information provided by the homecare provider (i.E.Absolute respiratory care), and our knowledge of the product.The homecare provider reported that the subject mr850 humidifier, which was initially used with the ltv1150 ventilator and pulmonetics/airlife breathing circuit, was tested at their office and no fault was found during inspection.It was also reported that the condensation observed in the subject breathing circuit was due to the electric fans inside the room that were constantly turned on while the therapy was being administered.The homecare provider also commented that the environmental condition at the patient's house was unstable.When reporting the complaint, the homecare provider confirmed that the patient was in stable condition and that the subject mr850 humidifier was replaced with the hc550 respiratory humidifier.The fph hc500 series respiratory humidifiers are intended to deliver optimal humidity to pediatric and adult patients in their homes.The homecare provider confirmed that the subject mr850 humidifier was functioning correctly during inspection and that the reported condensation was influenced by environmental conditions.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple set-up and environmental factors.The product technical manual (ptm) that accompany the mr850 respiratory humidifier state that the device is "designed for use in hospital intensive care units".Further, it also states "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety.".

Event Description

A hospital in (b)(6) reported that a set up, which involved a fisher & paykel healthcare (fph) mr850 respiratory humidifier, ltv1150 ventilator and pulmonetics/airlife breathing circuit, was allegedly over heating and more than normal condensate was found in the breathing circuit.They further reported that the ventilation was disrupted and that the patient's heart rate and respiratory rate increased and a mild burn was noted on the circumference of the tracheostomy stoma.The patient's condition was reported to be stable and that nystatin lotion was used on the reported burn.

• 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: 5618889
• MDR Text Key: 44723654
• Report Number: 9611451-2016-00187
• 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: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• 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