BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMAFLOAT

    MDR report key: 16690667 · Received April 6, 2023

    Report

    Report Number
    3009402404-2023-00014
    Event Type
    Death
    Date Received
    April 6, 2023
    Date of Event
    March 4, 2023
    Report Date
    April 6, 2023
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 ON (B)(6) 2023 AT 4:40PM STAFF AT THE FACILITY HEARD THE RESIDENT CALLING OUT AND ENTERED THE ROOM AND FOUND THE RESIDENT ON THE FLOOR ON HER STOMACH PARALELL TO HER BED. THE RN ASSESSED THAT THERE WAS A LACERATION ON HER FOREHAD, NO OTHER VISIBLE INJURIES, 9-1-1 WAS CONTACTED, RESIDENT WAS TRANSPORTED VIA AMBULANCE TO THE LOCAL EMERGENCY ROOM. SHE WAS DIAGNOSED WITH SUBARACHNOID AND SUBDURAL HEMORRHAGE. SHE REMAINED IN THE HOSPITAL UNTIL (B)(6) 2023 AND DID EXPIRE IN THE FACILITY ON (B)(6) 2023. THE FACILTY SELF REPORTED THIS THE STATE AGENCY ((B)(6) DEPARTMENT OF HEALTH) ON (B)(6) 2023 WITH A FOLLOW UP INVESTIGATION THAT WAS SUBMITTED ON (B)(6) 2023. THE FACILITY INVESTIGATION REVEALED THAT THIS RESIDENT HAD RECEIVED A NEW REPLACEMENT MATTRESS THAT WAS RENTED FROM JOERNS, DELIVERY WAS THE EVENING OF (B)(6) 2023. THE FACILITY RECEIVED NO DOCUMENTATION AT THE TIME OF DELIVERY, OR AFTERWARDS, AND IS NOT AWARE OF THE MAKE, MODEL OR SERIAL NUMBER OF THE LOW AIR LOSS MATTRESS. JOERNS PICKED THE MATTRESS ON MONDAY (B)(6), 2023, SINCE THE FACILITY CHANGED THE PLAN OF CARE AND THIS WAS NO LONGER INDICATED. COMPLAINT# AND RA#: (B)(4). WAS ENTERED INTO OUR SYSTEM TO HAVE THE PRODUCTS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE PRODUCTS HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533120 DERMAFLOAT PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DFLAL-4280-M

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Death| H