BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISE 1000 EX

    MDR report key: 18363478 · Received December 20, 2023

    Report

    Report Number
    3009402404-2023-00048
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    October 23, 2023
    Report Date
    December 20, 2023
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT ON 10/2323 AN ECMO PATIENT ROLLED OUT OF THEIR BARIATRIC BED AND FELL ONTO THE FLOOR RESULTING IN A DISLODGED LINE, REQUIRING ADDITIONAL TREATMENT. THE CAUSE OF THE FALL IS UNKNOWN AT THIS TIME. ONCE THE PATIENT WAS ASSISTED BACK INTO THE BED, NURSING NOTICED ONE OF THE AIR CELLS HAD BEEN DEFLATED. COMPLAINT # (B)(4) AND RA #84093826 WERE ENTERED INTO OUR SYSTEM TO HAVE THE DEVICE RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE UNITS HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205571 ARISE 1000 EX PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE AREXLAL-4888NZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other