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

Model Number	MR850
Medical Device Problem Codes	Off-Label Use (1494); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fisher & paykel healthcare is currently in the process of completing the investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in china reported, via the nmpa reporting system, that a ventilated patient desaturated to 60% spo2 and became cyanotic while receiving humidification via an mr850 respiratory humidifier.The patient was re-intubated and it was identified that there was mucus plug blocking the endotracheal tube.The healthcare facility also reported that after changing the endotracheal tube, the patient's oxygen saturation and vital signs returned to normal.
Event or Problem Description
A healthcare facility in china reported, via the nmpa reporting system, that a ventilated patient desaturated to 60% spo2 and became cyanotic while receiving humidification via an mr850 respiratory humidifier.The patient was re-intubated and it was identified that there was mucus plug blocking the endotracheal tube.The healthcare facility also reported that after changing the endotracheal tube, the patient's oxygen saturation and vital signs returned to normal.
Additional Manufacturer Narrative
(b)(6) correction: pma/510(k) number corrected to: k073706.Section h11: method: the subject mr850 respiratory humidifier was requested to be returned to fisher & paykel (f&p) healthcare in new zealand for evaluation however the healthcare facility requested the device to be assessed onsite.A f&p healthcare representative from china visited the healthcare facility and assessed the subject device onsite.Our investigation is therefore based on the information provided by the customer, the f&p healthcare representative, and our knowledge of the product.Results: the customer initially reported that a ventilated patient desaturated to 60% spo2 and became cyanotic while receiving humidification via an mr850 respiratory humidifier.The patient was re-intubated, and it was identified that there was mucus plug blocking the endotracheal tube.The healthcare facility also reported that after changing the endotracheal tube, the patient's oxygen saturation and vital signs returned to normal.The f&p healthcare representative reported that they carried out functional testing of the subject mr850 respiratory humidifier onsite.This testing was conducted with a f&p healthcare breathing circuit.It was confirmed that the subject device functioned as intended with no anomalies observed.The f&p healthcare representative also confirmed that a non-f&p healthcare breathing circuit was used at the time of the reported event.Conclusion: our evaluation confirmed that the mr850 respiratory humidifier was functioning as intended.The mr850 respiratory humidifier has several mechanisms to ensure that adequate humidity is provided to the patient.The mr850 respiratory humidifier features an audible and visual alarm which alerts the user if the displayed temperature exceeds 41°c, or if the airway temperature exceeds 43°c and immediately disables the heater-wire and the heater-plate.During use, the mr850 also features a visual low temperature warning which alerts the user if the displayed temperature drops below 35.5°c for 25 seconds.This warning will alert the user that low humidity is being delivered to the patient.If the temperature continues to remain below 35.5°c, an audible alarm will also be activated.If, during operation, the airway temperature decreases below 29.5 °c, a visible and audible low temperature alarm will be activated immediately.The user instructions which accompany the mr850 respiratory humidifier state the following: - "the use of breathing circuits, chambers, other accessories or parts which are not approved by fisher & paykel healthcare may impair performance or compromise safety." - "use of damaged components or accessories may impair the performance of this device or compromise safety." - "ensure that appropriate ventilator and/or patient monitor alarms are set, connections are secure and a leak test is completed before use." - "to prevent disconnection of the tubing or tubing system during use, only tubes in compliance with iso 5367 or iso 80601-2-74 should be used.".

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: RESPIRATORY HUMIDIFIER
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19672971
• Report Number: 9611451-2024-00490
• Device Sequence Number: 20771175
• Product Code: BTT
• UDI-Device Identifier: 09420012407177
• UDI-Public: (01)09420012407177(10)2101393027(11)201118
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2101393027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male