BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP S/T

    MDR report key: 13560232 · Received February 18, 2022

    Report

    Report Number
    2518422-2022-05568
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 19, 2022
    Report Date
    October 21, 2025
    Manufacturer
    RESPIRONICS, INC
    Product Code
    MNS
    UDI-DI
    00606959012554
    PMA / PMN Number
    K092818
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ALLEGING VISUALIZATION OF PARTICLES RELATED TO THE BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DESPITE MULTIPLE ATTEMPTS ON 06/02/2022, 08/09/2022/, 08/12/2022, THE DEVICE HAS NOT YET RETURNED 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 VISUALIZATION OF PARTICLES RELATED TO THE BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13318 BIPAP S/T VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC DS1060HS 00606959012554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown