BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP S/T CSERRIES

    MDR report key: 12828526 · Received November 17, 2021

    Report

    Report Number
    2518422-2021-06897
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    November 6, 2021
    Report Date
    February 23, 2023
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959015753
    PMA / PMN Number
    K092818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A BIPAP S/T CSERIES DEVICE ALLEGEDLY SHUT DOWN WHILE IN PATIENT USE. THE PATIENT WAS CYANOTIC AND TACHYCARDIC. THE PATIENT WAS PLACED ON ANOTHER NON INVASIVE VENTILATOR AND THE PATIENT RECOVERED. DESPITE SEVERAL ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP S/T CSERIES DEVICE SHUT DOWN WHILE IN PATIENT USE. THE PATIENT WAS CYANOTIC AND TACHYCARDIC. THE PATIENT WAS PLACED ON ANOTHER NON INVASIVE VENTILATOR AND THE PATIENT RECOVERED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726490 BIPAP S/T CSERRIES VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILIPS RESPIRONICS, INC. CN1067HS 00606959015753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention