BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR MATTRESS AND CONTROL UNIT

    MDR report key: 7914443 · Received September 27, 2018

    Report

    Report Number
    3009402404-2018-00063
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 26, 2018
    Manufacturer
    FXI
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY INVOLVED WILL NOT RELEASE THE PRODUCT TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "PATIENT SUSTAINED C-1 AND C-2 VERTEBRAE INJURIES AFTER BEING FOUND ON FLOOR. CODE BLUE WAS CALLED AND PATIENT WAS TRANSFERRED TO ICU D UNIT ON THE INVOLVED EQUIPMENT. THE PATIENT WAS PUT BACK ON TO THE INVOLVED EQUIPMENT AFTER THEIR FALL. THE PATIENT REMAINED ON THE BED FOR APPROXIMATELY TWO DAYS BEFORE BEING REMOVED SUNDAY NIGHT (B)(6) 2018." COMPLAINT# (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756677 AIR MATTRESS AND CONTROL UNIT PATIENT AIR MATTRESS FNM FXI 999-3322

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization