BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A30, CHINA

    MDR report key: 22142166 · Received June 4, 2025

    Report

    Report Number
    2518422-2025-106328
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    April 30, 2025
    Report Date
    March 2, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959067530
    PMA / PMN Number
    K113053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION ALLEGING THE PATIENT WAS GIVEN NON-INVASIVE VENTILATOR-ASSISTED VENTILATION ACCORDING TO THE DOCTOR'S INSTRUCTIONS, BUT THE PATIENT COMPLAINED OF CHEST TIGHTNESS AND OBVIOUS ASTHMA. THE DEVICE WAS CHECKED AND IT WAS FOUND THAT THE VENTILATOR WAS UNDER VENTILATED AND THE TIDAL VOLUME WAS LOW. THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE MANUFACTURER PREVIOUSLY REPORTED THIS AS A SERIOUS INJURY, AFTER FURTHER REVIEW, THIS REPORT WILL NOW BE FILED AS A PRODUCT PROBLEM. THIS NOTIFICATION WAS REVIEWED DUE TO A REPORT OF AN ELDERLY MALE, ADMITTED TO THE HOSPITAL DUE TO LUNG INFECTION, AND AFTER ADMISSION, BLOOD GAS EXAMINATION SHOWED TYPE 2 RESPIRATORY FAILURE, AND CO2 RETENTION. PATIENT WAS PRESCRIBED NON-INVASIVE VENTILATOR-ASSISTED VENTILATION ACCORDING TO THE DOCTOR'S INSTRUCTIONS, AND THE PATIENT USED IT NORMALLY. ON 4/30 PATIENT COMPLAINED OF CHEST TIGHTNESS AND EXHIBITED SIGNS OF ASTHMA. THE VENTILATOR WAS ASSESSED AND FOUND THAT ¿THE VENTILATOR WAS UNDER VENTILATED AND THE TIDAL VOLUME WAS LOW AND WAS REPLACED WITH ANOTHER VENTILATOR AFTER CHECKING THAT THERE WAS NO PROBLEM WITH EACH PIPELINE.¿ BASED ON THE INFORMATION CURRENTLY PROVIDED AND AVAILABLE, THE REPORTED CHEST TIGHTNESS AND SIGNS OF ASTHMA ARE ASSESSED AS NON-SERIOUS INJURIES. THEREFORE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. NO FURTHER ACTION IS REQUIRED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT WAS GIVEN NON-INVASIVE VENTILATOR-ASSISTED VENTILATION ACCORDING TO THE DOCTOR'S INSTRUCTIONS, BUT THE PATIENT COMPLAINED OF CHEST TIGHTNESS AND OBVIOUS ASTHMA. THE DEVICE WAS CHECKED AND IT WAS FOUND THAT THE VENTILATOR WAS UNDER VENTILATED AND THE TIDAL VOLUME WAS LOW. THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. CLINICAL ASSESSMENT INFO - THIS NOTIFICATION WAS REVIEWED DUE TO A REPORT OF AN ELDERLY MALE, ADMITTED TO THE HOSPITAL DUE TO A LUNG INFECTION, AND AFTER ADMISSION, BLOOD GAS EXAMINATION SHOWED TYPE TWO RESPIRATORY FAILURE, AND CO2 RETENTION. THE PATIENT WAS PRESCRIBED NON-INVASIVE VENTILATOR-ASSISTED VENTILATION ACCORDING TO A DOCTOR'S INSTRUCTIONS, AND THE PATIENT USED IT NORMALLY. ON (B)(6) 2025, THE PATIENT COMPLAINED OF CHEST TIGHTNESS AND EXHIBITED SIGNS OF ASTHMA. THE VENTILATOR WAS ASSESSED AND FOUND THAT THE VENTILATOR WAS UNDER VENTILATED AND THE TIDAL VOLUME WAS LOW AND WAS REPLACED WITH ANOTHER VENTILATOR AFTER CHECKING THAT THERE WAS NO PROBLEM WITH EACH PIPELINE. BASED UPON THE INFORMATION PROVIDED AND CURRENTLY AVAILABLE, THE DEVICE CAUSE AND/OR CONTRIBUTION TO THE REPORTED EVENT CANNOT CURRENTLY BE CONFIRMED, NOR REFUTED, BASED ON THE EVIDENCE PRESENT. FURTHER GOOD FAITH EFFORTS AND INFORMATION GATHERING ARE REQUIRED TO DISPOSITION THE DEVICE CAUSE AND/OR CONTRIBUTION TO THE PATIENT HARMS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466973 BIPAP A30, CHINA VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. CN1111143 00606959067530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention