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

Model Number MR850

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint mr850 humidifier and rt132 infant circuit were not returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.Our investigation is therefore based on the photographs and information provided by the hospital.Result: the photographs provided show that a sebac humidifier chamber 04314ns and sebac vni infant flow circuit were connected to the rt132 circuit.The hospital doctor stated that the sebac chamber was manually filled with water and the hospital biomed stated that misuse not a fault with the humidification system, contributed to the event.Fph has received no information from the hospital indicating a fault with the mr850 humidifier or the rt132 infant circuit.Conclusion: user error contributed to the event.The sebac chamber and circuit used with the mr850 humidifier and rt132 circuit are not approved fph products.Our user instructions that accompany the mr850 respiratory humidifier states: -the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety.An fph representative held four training sessions with the hospital staff and has shown staff how to correctly use the mr850 humidifier.After completing the training sessions the hospital staff have not observed any further condensation problems.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 use of third party breathing circuits not approved by fph.

Event Description

A hospital in (b)(6) reported to the ansm that the mr850 respiratory humidifier and a rt132 infant breathing circuit were used on a pediatric patient.A nurse removing circuit condensation disconnected the circuit and water rose up the nose of the patient.The flat heart tracing alarm was heard and the nurse removed the circuit from the patient and performed aspiration.The patient recovered and a physician was informed.The chest of the patient was x-rayed and there were no consequences from the inhaled condensation.

• 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7039995
• MDR Text Key: 93202357
• Report Number: 9611451-2017-01045
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2017

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2006
• 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