BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 16252794 · Received January 27, 2023

    Report

    Report Number
    2518422-2023-02968
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    August 27, 2021
    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 MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR TW 2840034 2518422-2022-103272. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    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 BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED HEADACHES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. AN INTERNAL VISUAL INSPECTION WAS COMPLETED BY THE MANUFACTURER. THE MANUFACTURER FOUND EVIDENCE OF INDETERMINATE BROWN CONTAMINANT ON THE UNDERSIDE OF THE TOP ENCLOSURE AND BACK SIDE OF FRONT PANEL, DUST-LIKE BEIGE CONTAMINATION NEAR AIR INTAKE OF BLOWER BOX, BLOWER BOX OUTLET, AND WITHIN BODY OF BLOWER BOX, DUST-LIKE AND HAIR-LIKE CONTAMINANTS ON THE SURFACE OF BLOWER. THE MANUFACTURER FOUND NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTURER CONCLUDES THE CONTAMINATES FOUND WERE CONSISTENT WITH DUST-LIKE BEIGE CONTAMINATION NEAR AIR INTAKE OF BLOWER BOX, BLOWER BOX OUTLET, AND WITHIN BODY OF BLOWER BOX AND INDETERMINATE BROWN CONTAMINANT ON THE UNDERSIDE OF THE TOP ENCLOSURE AND BACK SIDE OF FRONT PANEL, DUST-LIKE AND HAIR-LIKE CONTAMINANTS ON THE SURFACE OF BLOWER WERE INCONSISTENT WITH THE SOUND ABATEMENT FOAM. THE MANUFACTURER CONFIRMED THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616524 DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS(RESPIRATOR) BZD RESPIRONICS, INC. DSX700T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown