BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 13011895 · Received December 15, 2021

    Report

    Report Number
    2518422-2021-08162
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    November 18, 2021
    Report Date
    February 8, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING A CPAPDEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED AN UNSPECIFIED ILLNESS. THE PATIENT DID RECEIVE MEDICAL INTERVENTION AND REPORTED TO HAVE BEEN HOSPITALIZED. IN PREVIOUS REPORT, SECTION B5 WAS INCORRECT. CORRECT B5 SHOULD BE - 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 RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES AND UNSPECIFIED ILLNESS. THE PATIENT DID RECEIVE MEDICAL INTERVENTION AND REPORTED TO HAVE BEEN HOSPITALIZED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION.THE MANUFACTURER ALSO RECEIVED HUMIDIFIER. AN INTERNAL VISUAL INSPECTIONS OF THE DEVICE AND HUMIDIFIER WAS COMPLETED BY THE MANUFACTURER AND FOUND KERATIN-LIKE CONTAMINATION WAS PRESENT ON THE BLOWER BOX OUTLET, HAIR LIKE CONTAMINATION WAS OBSERVED ON THE HUMIDIFIER AIR OUTLET, INSIDE HUMIDIFIER AIR OUTLET, IN THE HUMIDIFIER ENCLOSURE, ON THE DRYBOX SEAL, AND ON THE BACK PANEL CONNECTOR. THE MANUFACTURER FOUND NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND 0 ERRORS. THE DEVICE WAS APPLIED POWER AND THE DEVICE OPERATED PROPERLY. THE MANUFACTURER CONCLUDES CONTAMINATION OF HAIR AND KERATIN FOUND WERE INCONSISTENT WITH THE DEVICE AND HUMIDIFIER. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. IN THIS REPORT, SECTION D9, D10, G3, H3, H6 HAS BEEN UPDATED OR CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED AN UNSPECIFIED ILLNESS. THE PATIENT DID RECEIVE MEDICAL INTERVENTION AND REPORTED TO HAVE BEEN HOSPITALIZED. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912724 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O HUMIDIFIER DSXHCP (SN H22587423BB0F)