BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE 5000

    MDR report key: 10621728 · Received October 2, 2020

    Report

    Report Number
    3007420694-2020-00157
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    July 20, 2020
    Report Date
    October 2, 2020
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER MANUAL DEDICATED TO ENTERPRISE 5000 (746-445) CONTAINS ALL CRUCIAL INFORMATION AND WARNINGS WHICH SHOULD BE FOLLOWED TO ENSURE THE SAFE USE OF THE BED: 'LOWER THE BED TO MINIMUM HEIGHT WHEN THE PATIENT IS LEFT UNATTENDED'. 'SAFETY SIDES ARE NOT INTENDED TO RESTRAIN PATIENTS WHO MAKE A DELIBERATE ATTEMPT TO EXIT THE BED.' THIS BED WAS SERVICED INTERNALLY BY THE CUSTOMER AND THERE WAS NO DEVICE FAILURE REPORTED TO ARJO. TO SUM UP, ARJO MEDICAL BED WAS USED FOR A PATIENT TREATMENT WHEN THE EVENT OCCURRED AND FROM THAT PERSPECTIVE, IT PLAYED A ROLE IN THE EVENT. NO MALFUNCTION WAS REPORTED. IT WAS DECIDED TO REPORT THIS EVENT DUE TO THE PATIENT FALL FROM THE ARJO BED AND SUSTAINED INJURY.

    Description of Event or Problem · 1

    A FACILITY NURSE MANAGER REPORTED TO ARJO THAT A PATIENT SLIPPED AND FELL TO THE FLOOR HITTING HER ELBOW. AS A CONSEQUENCE THE PATIENT SUSTAINED AN ELBOW FRACTURE AND MEDICAL INTERVENTION WAS REQUIRED. THE ELBOW WAS PUT IN A CAST AND AFTER TWO DAYS IN THE HOSPITAL, THE PATIENT WAS DISCHARGED HOME. INFORMATION GATHERED ALLOWED TO ESTABLISH CIRCUMSTANCES SURROUNDING THE EVENT. AT NIGHT THE PATIENT, USING A FREE SPACE BETWEEN THE RAISED SAFETY SIDE RAIL AND BED'S FOOTBOARD, GOT OUT OF THE ENTERPRISE 5000 BED . WHEN SHE WAS TRYING TO GET BACK THROUGH THE SAME SPACE BETWEEN SIDE RAIL AND FOOTBOARD, SHE SLIPPED AND FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084427 ENTERPRISE 5000 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB 5000KD24A22CF

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Hospitalization| R