BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV H/ HT/W, DS

    MDR report key: 17994998 · Received October 24, 2023

    Report

    Report Number
    2518422-2023-27611
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    July 22, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1973-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-510276) REGARDING THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT ALLEGES "SINUS ISSUES ALONG WITH HEADACHE AND DIZZINESS". THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. INTERNAL EVALUATION OF THE DEVICE FOUND EVIDENCE OF THIRD PARTY OR USER REPAIR. A THIRD-PARTY BLOWER BOX WITH NO SOUND ABATEMENT FOAM WAS PRESENT. THE ALARM RIBBON CABLE WAS DISCONNECTED FROM P5. NO FURTHER EVALUATION WAS POSSIBLE DUE TO THIRD PARTY MODIFICATION. PIL IS ALSO UNABLE TO ADDRESS THE SYMPTOMS DESCRIBED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813424 DREAMSTATION BIPAP AUTOSV H/ HT/W, DS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900T11W

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown