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

Model Number MR850

Device Problems Detachment Of Device Component (1104); Device Handling Problem (3265)

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

Event Date 03/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital to determine if the complaint mr850 humidifier caused or contributed to the reported event.We are also attempting to obtain the subject complaint device for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the temperature probe connected to an mr850 respiratory humidifier became detached from the circuit.It was further reported that the patient desaturated.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the subject mr850 respiratory humidifier and its accessories were not returned to fph in (b)(4) for evaluation.Questions were sent in an effort to obtain further information, however no response has been received.Our investigation is accordingly based on the information reported by the healthcare facility and our knowledge of the product.It was reported that the temperature probe connected to an mr850 respiratory humidifier dislodged and was not placed back immediately into the breathing circuit.It was further reported that humidity increased and the patient desaturated.No further patient consequence was reported.Conclusion: a temperature probe can get dislodged from a breathing circuit, if it is not correctly and securely fitted according to user instructions.This can happen, especially when using a non-fph breathing circuit with the mr850.We are unable to confirm the reported event.Based on our investigation, it is likely that the temperature sensor has become dislodged due to user error in the set-up of the mr850 and its accessories.The patient was a neonate treated in a neonatal unit.This patient population can be very unstable and therefore can be very sensitive to any changes in their therapy setup and environment.Even a minor change in the setup can lead to a desaturation.Therefore, neonatal patients are heavily monitored by electronic monitors and/or suitably qualified medical staff.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°c.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 respiratory humidifier also complies with the requirements specified on the iso 8185 respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems.This standard contains several requirements relating to the safety and performance of respiratory humidification systems.To prevent thermal injury, the standard also includes maximum enthalpy limits for humidified gas delivered through respiratory humidification systems.The mr850 also complies with the medical devices directive 93/42 eec, annex i "essential requirements".The user instructions provided with the mr850 respiratory humidifier contains the following warning: - ensure that both temperature probes are correctly and securely fitted.Failure to do so may result in temperatures in excess of 41°c being delivered to the patient.- the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety the user instructions also state: - push the chamber probe and airway probe into the breathing circuit.Make sure the chamber probe is correctly located in its key-way and that both probes are pushed home.Breathing circuits like the fph rt265 infant breathing circuit, contain the following warning in the user instructions: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.

Event Description

A healthcare facility in (b)(4) reported via a fisher & paykel healthcare (fph) field representative that the temperature probe connected to an mr850 respiratory humidifier became detached from the circuit.It was further reported that the patient desaturated.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: irfanali kermalli ; 173 technology dr. suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6502654
• MDR Text Key: 73382221
• Report Number: 9611451-2017-00340
• 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,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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: 03/20/2017
• 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: Reuse
• Patient Sequence Number: 1