BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 16172935 · Received January 16, 2023

    Report

    Report Number
    2518422-2023-01689
    Event Type
    Injury
    Date Received
    January 16, 2023
    Date of Event
    January 6, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1973-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGED BOX B: ADVERSE EVENT/PRODUCT PROBLEM FROM PRODUCT PROBLEM TO ADVERSE EVENT CHANGED OUTCOMES ATTRIBUTED TO AE FROM BLANK TO REQUIRED INTERVENTION. BOX D: CHANGED PRODUCT BRAND NAME FROM DREAMSTATION BIPAP TO DREAMSTATION BIPAP AUTOSV. CHANGED FDA "PRODUCT" CODE FROM BZD TO MNS. CHANGED COMMON DEVICE NAME FROM VENTILATOR,NON-CONTINUOUS (RESPIRATOR) TO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING. BOX G: CHANGED 510K FROM K131982 TO K090539. CHANGED BOX H: TYPE OF REPORTED COMPLAINT FROM PRODUCT PROBLEM TO SERIOUS INJURY. CHANGED PATIENT OUTCOME GRID FROM (B)(6). CHANGED HEALTH INCOME GRID FROM (B)(6). CHANGED "RECALL" (Z) NUMBER (RFB) FROM RES 88058 TO Z-1973-2021.

    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. 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
    1259057 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900H11C
    2156605 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention