BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24231461 · Received February 2, 2026

    Report

    Report Number
    9611451-2026-00173
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    December 28, 2025
    Report Date
    March 6, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: MR810AEA RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K131957. METHOD: THE SUBJECT MR810 RESPIRATORY HUMIDIFIER WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE MR810 RESPIRATORY HUMIDIFIER STOPPED HEATING DURING USE AND THE SEE MANUAL INDICATOR LIGHT WAS ILLUMINATED. ADDITIONALLY, IT WAS REPORTED THAT THE ALARM OF THE VENTILATOR IN USE AT THE TIME WAS ACTIVATED FOR "HIGH RESISTANCE". IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT DEVELOPED AN AIRWAY OBSTRUCTION, AND A BRONCHOSCOPY IDENTIFIED SPUTUM CRUSTS IN THE AIRWAY. THE PATIENT SUBSEQUENTLY REQUIRED A TRACHEOSTOMY. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, F&P HEALTHCARE'S INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE F&P HEALTHCARE MR810 RESPIRATORY HUMIDIFIER IS INTENDED TO PROVIDE HEAT AND HUMIDITY TO MEDICAL GAS. IT IS DESIGNED FOR USE WITH ARTIFICIAL VENTILATION SYSTEMS. PORTABLE VOLUME VENTILATION SYSTEMS, PRESSURE SUPPORT VENTILATION AND CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) SYSTEMS MAY INCORPORATE A MR810 RESPIRATORY HUMIDIFIER TO PROVIDE THERAPEUTIC LEVELS OF WARM HUMIDIFIED AIR TO PATIENTS WITH ARTIFICIAL AIRWAYS OR THROUGH MASK VENTILATION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR810 RESPIRATORY HUMIDIFIER STATES THE FOLLOWING INSTRUCTIONS FOR WHEN THE MANUAL INDICATOR IS FLASHING: "SEE MANUAL INDICATOR HUMIDIFIER FAULTY: IF THE RED LIGHT IS ILLUMINATED, THE HUMIDIFIER AND ALL ACCESSORIES SHOULD BE IMMEDIATELY REMOVED AND SENT FOR SERVICING."

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: MR810AEA RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K131957. FISHER & PAYKEL (F&P) HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CHINA REPORTED THAT AFTER TWO DAYS USE, THE MR810 RESPIRATORY HUMIDIFIER STOPPED HEATING DURING PATIENT USE. THE PATIENT WAS RECEIVING HEATED HUMIDIFICATION VIA THE SUBJECT DEVICE WHILE RECEIVING CONTINUOUS MECHANICAL VENTILATION. THE HEALTHCARE FACILITY STATED THAT "THE VENTILATOR ALARM WENT OFF, INDICATING DIFFICULTY IN AIR SUPPLY AND AIRWAY OBSTRUCTION." IT WAS REPORTED THAT THE ARTIFICIAL AIRWAY WAS OBSTRUCTED WITH SECRETIONS, AND THE PATIENT SUBSEQUENTLY REQUIRED A TRACHEOSTOMY. ADDITIONALLY, IT WAS REPORTED THAT AT THE TIME OF THE EVENT THE SEE MANUAL INDICATOR LIGHT WAS OBSERVED ON THE MR810 RESPIRATORY HUMIDIFIER. THE SUBJECT DEVICE WAS REPLACED.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE MR810 RESPIRATORY HUMIDIFIER DID NOT HEAT UP DURING PATIENT USE. THE PATIENT WAS RECEIVING HEATED HUMIDIFICATION DURING CONTINUOUS MECHANICAL VENTILATION AND THE HEALTHCARE FACILITY STATED THAT "THE VENTILATOR ALARM WENT OFF, INDICATING DIFFICULTY IN AIR SUPPLY AND AIRWAY OBSTRUCTION." IT WAS REPORTED THAT THE ARTIFICIAL AIRWAY WAS OBSTRUCTED WITH SECRETIONS, AND THE PATIENT SUBSEQUENTLY REQUIRED A TRACHEOSTOMY. ADDITIONALLY, IT WAS REPORTED THAT AT THE TIME OF THE EVENT THE MR810 RESPIRATORY HUMIDIFIER WAS OBSERVED TO BE ALARMING, AND THE SUBJECT DEVICE WAS SUBSEQUENTLY REPLACED. FISHER & PAYKEL (F&P) HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369107 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR810AEA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Required Intervention