BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOLERO

    MDR report key: 1828295 · Received September 2, 2010

    Report

    Report Number
    9611530-2010-00059
    Event Type
    Other
    Date Received
    September 2, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: "PER THE AHUS SERVICE TECHNICIAN" - "PATIENT HAD BEEN BATHED ON BOLERO LIFT. NURSE AIDE HAD LOWERED LIFT TO LOWEST POSITION AND PATIENT WAS PUTTING ON HIS SHIRT. LIFT BACK REST WAS IN FULL UP POSITION. PATIENT WAS SEATED WITH BACK ON RIGHT SIDE OF LIFT AS OPERATOR WOULD BE STANDING BEHIND THE DEVICE. FEET WERE ON LEFT SIDE. AS PATIENT PUT ON HIS SHIRT, LIFT TIPPED TOWARDS FEET SIDE OF LIFT. LIFT TIPPED ALL THE WAY TO THE FLOOR WITH LEG SIDE OF LIFT ON GROUND WITH PATIENT STILL SEATED ON LIFT. ENTIRE UNIT FLIPPED ONTO SIDE. BACK REST PORTION CAME FORWARD ONTO THE HEAD OF PATIENT BUT DID NOT RESULT IN ANY PATIENT INJURY. AIDE WAS UNSURE IF REAR CASTORS WERE IN LOCKED POSITION WHEN QUESTIONED BY FACILITY STAFF MANAGEMENT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLERO LIFT, PATIENT, NON AC POWERED FSA ARJO HOSPITAL EQUIPMENT AB CEB6003-01

    Patients

    Seq Age Sex Outcome Treatment
    1