BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACARE FULL ELECTRIC BED

    MDR report key: 3122523 · Received May 16, 2013

    Report

    Report Number
    3009402404-2013-00020
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY ((B)(6)), PER THE FACILITY, THE RESIDENT WAS BEING TREATED AND THE BED WAS RAISED TO A HIGH POSITION AS RESIDENT WAS BEING TURNED. THE PIN THAT HOLDS THE TOP OF THE BED, FELL OUT AND THE TOP OF THE BED COLLAPSED. THE RESIDENT SLID AND HIT THE HEADBOARD. THE BED ALSO HIT THE NURSE ASSISTANT, WHO WAS ALSO BEING SEEN AT THE HOSPITAL. THE HOSPITAL WAS (B)(6). POSSIBLE BROKEN SHOULDER WAS REPORTED, BUT NOT CONFIRMED. CONTACT WAS MADE ON (B)(4) 2013 WITH (B)(6), ADMINISTRATOR AT THE FACILITY, WHO STATED THAT THEY WERE IN THE PROCESS OF INVESTIGATING THE INCIDENT. AFTER THE INITIAL CONTACT, SEVERAL CALLS WERE MADE TO THE FACILITY ((B)(6)) ON MULTIPLE OCCASIONS WITH NO FURTHER RESPONSE FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217815 ULTRACARE FULL ELECTRIC BED PATIENT HOSPITAL BED FNL JOERNS HEALTHCARE U770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization