BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLERO

    MDR report key: 17648490 · Received August 30, 2023

    Report

    Report Number
    1419652-2023-00050
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    June 1, 2022
    Report Date
    August 30, 2023
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED OF A COMPLAINT REGARDING A BOLERO BATH STRETCHER. ACCORDING TO THE INFORMATION PROVIDED THE DEVICE HAD A DAMAGED FABRIC, THE HANDLES WERE CORRODED AND WITHOUT RUBBER GRIPS. THE ACTUATOR WAS JAMMING. THE ARJO WAS REQUESTED FOR SERVICE. DURING AN ARJO SERVICE TECHNICIAN VISIT AT THE CUSTOMER SITE, THE ARJO SERVICE TECHNICIAN WAS INFORMED THAT THE PATIENT HAD SUFFERED A PELVIC GIRDLE FRACTURE WITHOUT DISPLACEMENT IN (B)(6) 2022, AS THE PATIENT HAD FALLEN FROM THE BOLERO DEVICE. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT FELL OFF THE DEVICE BECAUSE CURLED UP DUE TO A SPASM. AS THE TROLLEY WAS WET, THE NURSES FAILED TO PREVENT THE PATIENT FROM FALLING. THERE WAS NO NEED FOR A PLASTER CAST, ONLY IMMOBILISATION OF THE PATIENT. THE SAFETY BELTS WERE NOT IN USE. BEFORE THE INCIDENT THE PATIENT WAS AFTER A STROKE INCIDENT AND IMMOBILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417066 BOLERO LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB CEB6000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization