BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARI10A BED

    MDR report key: 17262167 · Received July 5, 2023

    Report

    Report Number
    3009402404-2023-00029
    Event Type
    Death
    Date Received
    July 5, 2023
    Date of Event
    May 27, 2023
    Report Date
    July 5, 2023
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    OSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMTION 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 CNA LOCKED BED RAILS PRIOR TO PROVIDING CARE. RESIDENT USED BED RAILS FOR BED MOBILITY AND SUPPORT. AFTER APPROXIMATELY 3 MINUTES BEDRAIL LOCK RELEASED ON ITS OWN AND RESIDENT FELL TO THE FLOOR. COMPLAINT # (B)(4) AND RA # (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE UNIT RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE BED HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787362 BARI10A BED PATIENT BARIATRIC BED OSI JOERNS HEALTHCARE BARI10A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death