BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 15986358 · Received December 15, 2022

    Report

    Report Number
    2518422-2022-101965
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 29, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: BOX B: FROM PRODUCT PROBLEM TO BOTH/OTHER. BOX H: FROM PRODUCT PROBLEM TO SERIOUS INJURY. GRID: POC: FROM (B)(4). HIC: FROM (B)(4).

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORT OF SERIOUS 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
    1439077 DREAMSTATION AUTO BIPAP DREAMSTATION AUTO BIPAP BZD RESPIRONICS, INC. DSX700S11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other