BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 12688969 · Received October 25, 2021

    Report

    Report Number
    2518422-2021-05664
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    July 23, 2021
    Report Date
    December 6, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, THE DEVICE NOT CONTAIN SOUND ABATEMENT FOAM THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AND IS NOT IN SCOPE OF RES 88058. THEREFORE, THERE IS NO ALLEGATION OF A REPORTABLE EVENT ASSOCIATED WITH THE DEVICE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. SECTION H6 MEDICAL DEVICE PROBLEM CODE WAS CODED INCORRECTLY ON THE PREVIOUS REPORT.

    Description of Event or Problem · 1

    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. 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
    1591970 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown