BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYCARE

    MDR report key: 19347790 · Received May 17, 2024

    Report

    Report Number
    3009402404-2024-00021
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 17, 2024
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, 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 DS CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: A BED. DS REPORTED THAT THE FOLLOWING OCCURRED AT 10:00 PM ON (B)(6) 2024: THE STAFF REPORTED THAT THE BED STARTED SHOOTING SPARKS AND SMOKING FROM UNDERNEATH LAST NIGHT LAST NIGHT. THEY UNPLUGGED IT AND TOOK IT OUT OF USE. THE RESIDENT WAS IN THE ROOM, BUT NOT IN THE BED. HE LOOKED UNDER THE BED AND HE COULDN'T FIND ANY BURN MARKS ON ANY OF THE COMPONENTS. HE PLUGGED IT INTO THE SAME OUTLET AND ONE IN HIS SHOP AND NOTHING WORKS ON THE BED IN EITHER OUTLET. HE TRIED A NEW PENDANT AND THAT DID NOT HELP. HE PLUGGED ANOTHER BED INTO THE SAME OUTLET IN THE RESIDENT'S ROOM AND THAT BED WORKS FINE. THERE WERE NO INJURIES ACCORDING TO DS. THE PRODUCT HAS BEEN TAKEN OUT OF USE. WHEN ASKED ABOUT AN IDEAL OUTCOME, DS T SAID: HE SAID THE BED FRAME IS FINE, BUT ALL THE ELECTRONICS ON THE BED SHOULD BE REPLACED. HE CAN INSTALL ALL OF THOSE COMPONENTS HIMSELF. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400593 EASYCARE PATIENT BED FNL JOERNS HEALTHCARE ECS 600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other