BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14889264 · Received July 1, 2022

    Report

    Report Number
    2518422-2022-45411
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 23, 2022
    Report Date
    August 9, 2024
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 21, 2024, AND SECTION H11 SHOULD BE REPORTED AS: 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. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING DEVICE HAS STRANGE ODOR, HEADACHE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE DEVICE WAS EVALUATED AND MANUFACTURER AND OBSERVED THE FOLLOWING FROM AN EXTERNAL AND INTERNAL INSPECTION: UNKNOWN WHITE, AND BLACK CONTAMINATION (DUST LIKE) , INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM, AT THE AIR INLET OF THE BLOWER BOX. UNKNOWN WHITE, CONTAMINATION (DUST LIKE) , IN THE ISO PORT INTERNATIONAL ORGANIZATION OF STANDARDIZATION). DUST LIKE CONTAMINATION ON TOP AND BOTTOM OF THE BLOWER MOTOR AND THE BLOWER MOTOR SEAL. POTENTIAL MINERAL DEPOSIT SPOTS ON THE BOTTOM OF THE BLOWER MOTOR INDICATING POTENTIAL WATER INGRESS. POTENTIAL MINERAL DEPOSIT SPOTS ON THE BOTTOM OF THE BLOWER BOX INDICATING POTENTIAL WATER INGRESS. BLACK CONTAMINATION, CONSISTENT WITH KERATIN, AT THE AIR OUTLET OF THE BLOWER BOX. BLACK DUST IKE CONTAMINATION (INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM) IN THE BOTTOM OF THE ENCLOSURE. BLOWER MOTOR SEAL KINKED. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION IN THE DEVICE AND THEY WERE UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS DESCRIBED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING DEVICE HAS STRANGE ODOR, HEADACHE RELATED TO A 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
    2231969 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown