BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 16444842 · Received February 27, 2023

    Report

    Report Number
    2518422-2023-05815
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 16, 2023
    Report Date
    November 26, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED BY THE MANUFACTURER OBSERVED A LARGE, THICK, PIECE OF TAPE/FOAM-LIKE MATERIAL WITH FIBER-LIKE PARTICLES, ON THE BOTTOM ENCLOSURE. A DARK UNKNOWN RESIDUE WAS OBSERVED ON THE TOP ENCLOSURE, FRONT PANEL, BOTTOM ENCLOSURE, AND REAR PANEL. A BROWN UNKNOWN CONTAMINANT WAS OBSERVED ON THE BOTTOM ENCLOSURE. A HAIR-LIKE PARTICLE WAS OBSERVED ON THE FRONT PANEL. A HAIR-LIKE PARTICLE WAS OBSERVED IN THE BLOWER BOX. A KERATIN-LIKE SUBSTANCE WAS OBSERVED ON THE BLOWER SEAL AND BLOWER BOX. ER-2243857(V01) ADDRESSES THE ISSUE OF KERATIN. EVIDENCE OF LIQUID INGRESS WAS OBSERVED ON THE BLOWER. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED.

    Description of Event or Problem · 0

    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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED HAVING DIFFICULTY IN BREATHING . THERE WAS NO REPORT OF SERIOUS 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
    787285 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINIOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown