BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLERO

    MDR report key: 3234018 · Received July 11, 2013

    Report

    Report Number
    9611530-2013-00070
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). WHEN REVIEWING SIMILAR REPORTED EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (CASTOR FAILURE), WHICH WERE FOUND MAINLY RELATE TO USE ERROR. THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE ON BOLERO IS CONSIDERED TO BE LOW AND STABLE, TAKING INTO CONSIDERATION THAT OVER 8000 BOLEROS HAVE BEEN SOLD SINCE 1996. WE WERE ABLE TO FIND A DEFICIENCY WITH THE DEVICE, IT WAS MODIFIED BY THE CUSTOMER IN UNAUTHORIZED WAY. THIS MEANS THAT THE BOLERO DEVICE WAS NOT UP TO SPECIFICATION WHEN THE INCIDENT TOOK PLACE. THE DEVICE WAS NOT BEING USED FOR PT HANDLING AT THE TIME OF INCIDENT. FROM OUR EVALUATION IT APPEARS A NUMBER OF USE ERRORS CAUSED THE EVENT. THE MOST RELEVANT USE ERROR RELATED WITH THE UNAUTHORISED DEVICE MODIFICATION IN COMBINATION WITH DEVICE OVERLOAD AND LACK OF MAINTENANCE: IT IS STATED IN THE INSTRUCTION FOR USE (04.CE. 01/3 US CA DATED JUNE 1998): 'NOTE: MODIFICATIONS MADE TO THE EQUIPMENT WITHOUT ARJO'S EXPRESS ACKNOWLEDGEMENT WILL INVALIDATE SUPPLIER'S PRODUCT LIABILITY.' 'WARNING! DO NOT OVERLOAD! THE LIFTING CAPACITY OF THE LIFT BATH TROLLEYS 150KG (330 LB). THE PREVENTIVE CHECKS MUST BE DONE ACCORDING TO THE IFU MAINTENANCE PART. CHECK THAT THE WHEELS ON THE LIFT BATH TROLLEY HAVE BEEN CLEANED'. CHECK THAT ALL SCREWS AND NUTS ARE TIGHTENED AND THAT THERE ARE NO GAPS'. PLEASE BE AWARE THAT THIS DEVICE IS MORE THAN 10 YEARS OLD AND IT PASSED ITS INTENDED LIFETIME, AS THE IFU IS CLEARLY STATING: 'THE USEFUL LIFE OF THIS EQUIPMENT, UNLESS OTHERWISE STATED, IS TEN (10)YEARS, SUBJECT TO REQUIRED PREVENTIVE MAINTENANCE AS SPECIFIED IN ARJO'S OPERATING AND DAILY MAINTENANCE INSTRUCTION AND SPARE PART LIST.' WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS REC'D INFO AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE IFU SAFETY WARNING ARE FOLLOWED THERE WILL BE NO PT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320657 BOLERO FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1