BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER AIR II SYSTEM

    MDR report key: 9135122 · Received September 30, 2019

    Report

    Report Number
    3009402404-2019-00062
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 30, 2019
    Manufacturer
    FXI
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS EVALUATED BY THE DISTRIBUTER AND IT OPERATES TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "IT WAS ALLEGED THAT AT APPROX 8:32AM ON 8/21 A NURSE CALLED A CODE RESCUE FOR A PATIENT FOUND ON THE FLOOR. IN THE REPORT IT WAS NOTED THAT THE PATIENT ATTEMPTED TO GET OUT OF BED AND FELL. THE HEAD OF THE BED WAS IN A 30 DEGREE ANGLE AND THE MATTRESS WAS IN THE AUTO FIRM SETTING WITH THE RAILS HALF DOWN. THE PATIENT SUSTAINED BRUISING TO THE FACE ABOVE THE LEFT EYE. ALSO IT WAS TOLD THIS PATIENT IS IN COMFORT MEASURES ONLY." COMPLAINT (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931727 STRYKER AIR II SYSTEM PATIENT AIR MATTRESS FNM FXI 999-3322SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization