BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP S/T C SERIES

    MDR report key: 14160515 · Received April 20, 2022

    Report

    Report Number
    2518422-2022-13706
    Event Type
    Death
    Date Received
    April 20, 2022
    Date of Event
    April 10, 2022
    Report Date
    June 16, 2022
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959039209
    PMA / PMN Number
    K092818
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVING INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT WAS ALLEGEDLY IN THE HOSPITAL AND THE PATIENT'S BLOOD OXYGEN LEVEL DECREASED. THE DEVICE WAS CHANGED TO A DIFFERENT DEVICE. THE PATIENT EXPIRED AS A RESULT OF A CARDIAC ARREST. 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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT WAS ALLEGEDLY IN THE HOSPITAL AND THE PATIENT'S BLOOD OXYGEN LEVEL DECREASED. THE DEVICE WAS CHANGED TO A DIFFERENT DEVICE. THE PATIENT EXPIRED AS A RESULT OF A CARDIAC ARREST. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE CORRECTED INFORMATION IS: THE MANUFACTURER PREVIOUSLY REPORTED AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT WAS ALLEGEDLY IN THE HOSPITAL AND THE PATIENT'S BLOOD OXYGEN LEVEL DECREASED. THE DEVICE WAS CHANGED TO A DIFFERENT DEVICE. THE PATIENT EXPIRED AS A RESULT OF A CARDIAC ARREST. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT WAS IN THE HOSPITAL AND THE PATIENT'S BLOOD OXYGEN LEVEL DECREASED. THE DEVICE WAS CHANGED TO A DIFFERENT DEVICE. THE PATIENT EXPIRED AS A RESULT OF A CARDIAC ARREST. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410516 BIPAP S/T C SERIES VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILIPS RESPIRONICS, INC. 1067P 00606959039209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death