BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO, BASIC & SHOWER TROLLEY

    MDR report key: 1647984 · Received March 22, 2010

    Report

    Report Number
    9611530-2010-00015
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 3, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 ON OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJO INC, (B)(4). THE SUBMISSION OF THIS REPORT AND RELATED INFORMATION DOES NOT NECESSARY REFLECT A CONCLUSION BY ARJOHUNTLEIGH THAT THE REPORT OR INFORMATION IS AN ACKNOWLEDGEMENT THAT ARJOHUNTLEIGH, ARJOHUNTLEIGH EMPLOYEES OR ARJOHUNTLEIGH PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY CUSTOMER 03/05/2010: AFTER A TRANSFER FROM THE BED TO THE TROLLEY / STRETCHER, THE RESIDENT WAS BEING TRANSPORTED DOWN THE HALL TO THE BATHING ROOM. DURING THE MOVEMENT, THE RAIL CATCH CAME UNFASTENED ALLOWING THE RESIDENT TO ESCAPE THE STRETCHER AND FALL TO THE FLOOR. AN ARJOHUNTLEIGH INVESTIGATOR HAS EXAMINED THE DEVICE AND FOUND; GENERAL CONDITION OF DEVICE: THE TROLLEY PORTION OF THE UNIT IS IN EXCELLENT CONDITION. THE STRETCHER WAS REMOVED FROM AN OLDER MODEL SHOWER TROLLEY AND INSTALLED ON THE NEW TROLLEY. THE STRETCHER IS IN FAIR CONDITION. THE MATTRESS AND THE BELT RESTRAINT ARE IN GOOD WORKING CONDITION. FUNCTION TEST RESULTS (PROVIDE FULL DETAILS): THE TROLLEY PUMPS UP AND LOWERS PROPERLY. THE STRETCHER CLIPS WORK BUT NEED SPECIAL ATTENTION TO INSURE PROPER FASTENING. THE CLIPS WILL FASTEN PROPERLY, BUT THEY NEED TO BE WATCHED CLOSELY TO INSURE PROPER FASTENING. THE FACILITY HAS 8 UNITS, 2 OLDER UNITS ARE NOT GOING TO BE PUT BACK INTO SERVICE. ALL THE OTHER UNITS WILL HAVE THE CLIPS REPLACED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO, BASIC & SHOWER TROLLEY LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB BAB1000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization