BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14843186 · Received June 28, 2022

    Report

    Report Number
    2518422-2022-46600
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    December 24, 2021
    Report Date
    September 27, 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

    THE MANUFACTURER PREVIOUSLY REPORTED INCORRECT INFORMATION IN SECTIONS D2. THE CORRECTION INFORMATION IS REFLECTED IN THIS REPORT. D.2 SECTION INCORRECTLY REPORTED AS MNS PRODUCT IN THE PREVIOUS REPORT, WHICH IS CORRECTLY REPORTED AS BZD PRODUCT IN THIS FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY INCORRECTLY MARKED ON MANUFACTURER NARRATIVE ON SECTION H10 WHICH SHOULD HAVE BEEN UNMARKED.THE SECTION B4 DATE IN THE PREVIOUS REPORT WAS INCORRECT AND IT SHOULD HAVE BEEN 06/30/2022.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF PARTICLES. 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
    2018834 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C
    376224 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Female