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

Model Number MR850

Device Problem Increase in Pressure (1491)

Patient Problem Chest Tightness/Pressure (2463)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) method: the complaint mr850 respiratory humidifier was not returned to fisher & paykel healthcare for evaluation.Therefore, our investigation is based on the information provided by the hospital, previous similar investigations and our knowledge of the product.Results: it was reported that a third party breathing circuit manufactured by intersurgical was used in the setup at the time of the reported event.The hospital further reported that there was no patient consequence.A lot check could not be carried out as the lot information was not provided.Conclusion: based on the information provided, the condensation issue reported by the customer is most likely related to the use of a third party breathing circuit with the mr850 respiratory humidifier.Condensate in the humidification system 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 a number of multiple set up and environmental factors including third party breathing circuits not approved by fisher & paykel healthcare.The user instructions that accompany the mr850 respiratory humidifier state: "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety." since the reported incident a fisher & paykel healthcare representative has visited the hospital to answer any questions and address any condensation issues.No condensation issues were found during the rep's visit.

Event Description

A hospital in (b)(6) reported excessive condensation in the expiratory limb of an intersurgical breathing circuit.The setup also included a maquet servo i ventilator and a fisher & paykel healthcare (fph) mr850 respiratory humidifier.They further reported that the condensation affected the "pressure measurement" and that the filter on the expiratory limb required to be replaced four to six times a day.It was also reported that the patient was being ventilated for acute respiratory failure and that the event triggered a rise in the patient's intra-thoracic pressure.Further information received from the hospital revealed that there was no patient consequence.

• 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: 5277117
• MDR Text Key: 33056071
• Report Number: 9611451-2015-00523
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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: 11/09/2015
• 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
• Treatment: MAQUET SERVO I