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

Model Number MR850

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 12/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject mr850 humidifier was not returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.Our analysis is accordingly based on the additional information provided by the hospital and our knowledge of the product.The customer does not feel that there is a significant risk with the mr850 and does not believe that it caused the reported injury.Conclusion: user error contributed to the event.The customer was using third party breathing circuit (intersurgical) with the mr850 at the time of the reported event.Fisher & paykel healthcare warns against the use of third party components with our mr850 humidifiers.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.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.The mr850 humidification system is designed to heat up the water enough for gas humidification by evaporation.The amount of heating depends on the gas parameters, ambient conditions, and operating mode.Although the water is at an elevated temperature from ambient, the temperature (and hence the thermal energy) of the delivered gas to the patient is significantly lower.The mr850 humidification system has many means of protective measures; in particular there is a high temperature alarm, which is generated if the airway temperature exceeds 43 degrees celsius.The displayed temperature is an indication of the dew point of the gas, and hence the thermal energy associated.If this high temperature alarm is initiated the humidifier will immediately and automatically shut down all power to the heater wire and the heater plate.The mr850 complies with iso 8185:2007 'respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems'.

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare (fph) representative that a patient was set up on a ventilation system composed of fph mr850 respiratory humidifier, stellar ventilator and an intersurgical circuit.The patient developed blistering and burns to the skin on their left hand.No medical intervention apart from dressing to wound was required.No further patient consequence was reported.

• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 7239695
• MDR Text Key: 99100093
• Report Number: 9611451-2018-00086
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/05/2018

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: 150923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 02/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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
• Patient Age: 15 YR