BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 18705240 · Received February 14, 2024

    Report

    Report Number
    2518422-2024-07389
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 30, 2024
    Report Date
    June 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED THE CORD WAS MELTED TO THE PLUG IN AND STILL BURNING AND SMOKE WAS ALSO OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. DURING INTERNAL AND EXTERNAL INSPECTION, THE MANUFACTURE FLIP LID SEAL OUTER RIM HAD UNKNOWN CONTAMINATION ON IT. DRY BOX SEAL TO THE WATER TANK WAS NOT SEATED PROPERLY. WATER TANK WAS NOT RETURNED WITH THE HUMIDIFIER. BROWN AND BLACK DUST LIKE CONTAMINATION AND SOME POTENTIAL HAIRS/FIBERS IN THE BOTTOM OF THE HUMIDIFIER ENCLOSURE. THE CONTAMINATION FOUND IN THE HUMIDIFIER ENCLOSURE ARE CONSIDERED NOT TO BE IN THE AIRPATH. THE SOURCE OF CONTAMINATION WAS MOST LIKELY EXTERNAL TO THE DEVICE. DURING EXTERNAL VISUAL INSPECTION FOUND NO EVIDENCE OF DAMAGE OR FAILURE. THE MANUFACTURE PERFORMED DREAMSTATION MODEM EVALUATION PROCEDURE USING EFT 3100509 (VER 06) DREAMSTATION MODEM ERROR LOG READER CONFIGURATION POD. DREAMSTATION MODEM ERROR LOG READER SHOWED 1 ERROR LOGGED (ID 0). ACCORDING TO THE DREAMSTATION MODEM EVALUATION PROCEDURE THIS IS NO ISSUE AND ERROR CAN BE IGNORED. THE MANUFACTURE WAS ABLE TO CONFIRM THE COMPLAINT. BOX:H HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED THE CORD WAS MELTED TO THE PLUG IN AND STILL BURNING AND SMOKE WAS ALSO OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. 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
    529383 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male