BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 16470024 · Received March 2, 2023

    Report

    Report Number
    2518422-2023-06126
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 24, 2023
    Report Date
    November 26, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DREAMSTATION BIPAP AUTOSV H/HT/C DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE DEVICE HAS NO VISUALIZATION OF FOAM PARTICLES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS ROUTED TO SCRAP. THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THIS NOTIFICATION AND NO INCREASED RISK TO THE INTENDED USER. THIS DEVICE MEETS UL AND IEC REQUIREMENTS FOR FLAMMABILITY. BASED ON THE INFORMATION AVAILABLE, NO MDR WILL BE FILED.

    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 VISUALIZATION OF PARTICLES. 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
    517389 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown