BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTO BIFLEX

    MDR report key: 14288390 · Received May 5, 2022

    Report

    Report Number
    2518422-2022-17237
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 17, 2022
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959006010
    PMA / PMN Number
    K131982
    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

    IS THE ORIGINAL REPORT ASSOCIATED WITH THIS DEVICE. A DUPLICATE REPORT HAS BEEN SUBMITTED FOR THIS DEVICE UNDER REPORT MDR 2518422-2022-17238. THIS FOLLOW UP REPORT IS BEING FILED FOR AWARENESS OF THIS DUPLICATE REPORT. A CORRECTION REPORT MDR 2518422-2022-17238-1 HAS BEEN FILED FOR AWARENESS ABOUT THE DUPLICATE REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046258 BIPAP AUTO BIFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC DS760HS 00606959006010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown