BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 13003270 · Received December 14, 2021

    Report

    Report Number
    2518422-2021-08146
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 19, 2021
    Report Date
    January 24, 2023
    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

    THE MANUFACTURER WAS PREVIOUSLY 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 RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION.AN EXTERNAL VISUAL INSPECTION WAS COMPLETED BY THE MANUFACTURER AND FOUND NO SIGNS OF CONTAMINATION ON THE OUTSIDE OF THE DEVICE. AN INTERNAL VISUAL INSPECTION WAS COMPLETED BY THE MANUFACTURER.THE MANUFACTURER FOUND DUST CONTAMINATION ON BLOWER MOTOR. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND NO ERROR LOGGED.THE DEVICE WAS HOOKED UP TO POWER SUPPLY, AIRFLOW WAS VERIFIED AND THE DEVICE OPERATED PROPERLY. THE MANUFACTURER CONCLUDES NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTURER CONFIRMS DUST CONTAMINATION ON THE BLOWER MOTOR. THE HUMIDIFIER WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. THE MANUFACTURER FOUND EVIDENCE OF CONTAMINATION ON THE BOTTOM ENCLOSURE. SECTION D9, G3, H6 HAS BEEN UPDATED / CORRECTED.

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUSLY SUBMITTED REPORT, SECTION B2 WAS SELECTED INCORRECTLY WHICH HAS BEEN CORRECTED IN THIS REPORT. SECTION B2 HAS BEEN CORRECTED / UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894658 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability HUMIDIFIER DSXHCP (H23260019E8C1)