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

Model Number MR850

Device Problem Moisture Damage (1405)

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

Event Date 02/26/2015

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported via a distributor that an mr850 humidifier set up with a mr370 reusable chamber and a drager evita v300 ventilator was causing excessive condensation.The hospital further reported that a patient inhaled the condensate and required additional treatment.The hospital requested functional checks on the mr850 humidifier.The patient was confirmed to have recovered with no adverse health consequences.

Manufacturer Narrative

(b)(4).The complaint mr850 humidifier is not due to be returned to fisher & paykel healthcare in (b)(4) for evaluation as the hospital continues to use it.We are currently working with the healthcare facility to complete our investigation.A follow up report will be provided upon completion of our evaluation.Customer has not returned the device.

Manufacturer Narrative

(b)(4).The complaint mr850 humidifier is not due to be returned to fisher & paykel healthcare (fph) in (b)(4) for evaluation as the hospital continues to use it.The hospital further reported that the patient fully recovered and has since been discharged from the facility.The hospital did not note the serial number of the complaint mr850 humidifier and none of the devices used during the alleged event were available for evaluation.Two fph product managers visited the hospital for two days and inspected all mr850 humidifiers used in the facility as well as the set ups used by the hospital.The distributor had previously inspected and performance tested many of the mr850s used in the facility.The summary of findings from the fph product managers' visit is as follows: user error in the set-up of mr850 humidifiers with non-fph breathing circuits; the mr850 humidifier humidity compensation mode was set incorrectly; the reusable paediatric drager circuit was found to be positioned higher than the endotracheal tube causing any condensation produced by cooling phases in the unheated portion of the circuit to drain into the endotracheal tube; a non-fph circuit watertrap was placed on the patient bed preventing the flow of condensate from the rest of the circuit to the watertrap.Condensate build up is influenced by equipment setup and environment.Common factors to be aware of include the use of non-fph breathing circuits, drafts due to air conditioning or cooling fans and low ambient temperatures.Other conditions can also compromise the humidity output from the humidifiers, including high room ambient temperatures (>26°c) combined with inlet gas which has been excessively heated by the ventilator.The mr850 is designed to compensate for some of these factors by activating the humidity compensation mode so that optimal levels of humidity can be generated for the patient.That being said, the mr850 humidification system is ultimately designed for use with fph chambers and breathing circuits.The interactions between the various components, namely the humidifier, the sensing probes, the chamber and the circuits are critical to ensuring safe and efficacious delivery of the therapy.In this case, the hospital was using a non-fph breathing circuit manufactured by (b)(6) even though our user instructions for the mr850 warns users agains using non fph breathing circuits with our humidifier.Specifically, our user instructions for mr850 states that "the use of breathing circuits, chambers or other accessories, which are not approved by fisher & paykel healthcare, may impair performance or compromise safety".The fph product managers provided hospital staff with correct training on the use and set-up of the mr850 humidifier and did not observe any condensation issues once the set up was corrected.

Event Description

A healthcare facility in (b)(6) reported via a distributor that an mr850 humidifier set up with a mr370 reusable chamber and a drager evita v300 ventilator was alleged to have caused excessive condensation.The hospital further reported that a patient allegedly inhaled the condensate and required additional treatment.The hospital requested functional checks on the mr850 humidifier.The patient was confirmed to have recovered with no adverse health consequences.

• 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: 4725569
• MDR Text Key: 19312097
• Report Number: 9611451-2015-00217
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRAGER EVITA V300 VENTILATOR; DRAGER EVITA V300 VENTILATOR; MR370 REUSABLE CHAMBER; MR370 REUSABLE CHAMBER