BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP

    MDR report key: 12558502 · Received September 30, 2021

    Report

    Report Number
    2518422-2021-04532
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 16, 2023
    Manufacturer
    RESPIRONICS,INC
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2021-03257-2. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT. SECTION D1, D4 AND H4 HAS BEEN CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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
    1455020 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DSX200H11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown