BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTROY

    MDR report key: 3022548 · Received March 21, 2013

    Report

    Report Number
    9611530-2013-00023
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER THE EXEMPTION (B)(4) BY THE MANUFACTURER (B)(4) ON BEHALF OF THE IMPORTER (B)(6). THE ENTROY LIFT IS A POOL LIFT FOR ASSISTED TRANSFER IN AND OUT OF THE POOL. IT CAN BE EQUIPPED WITH EITHER CHAIR OR STRETCHER. IT WAS REPORTED THAT THE BACKREST OF THE ENTROY STRETCHER MOVED UNCOMMANDEDLY. NO PT WAS ON THE LIFT AND IT WAS TAKEN OUT OF USE AS PER INSTRUCTIONS IN THE MANUAL. WE VISITED THE CUSTOMER SITE TO INSPECT THE LIFT AND FOUND THAT THE STRETCHER WORKED CORRECTLY WHEN ATTACHED TO THE WHEELED TRANSFER CHASSIS BUT THE BACK REST WOULD NOT WORK WHEN ATTACHED TO THE LIFTING PILLAR. THE HANDSET AND CONTACT PLATE CABLING WERE REPLACED AND THE DEVICE HAS BEEN PUT BACK INTO SERVICE. A THOROUGH INVESTIGATION HAS BEEN COMPLETED BY THE MANUFACTURER; A TREND REVIEW SHOWED THAT THIS HAS OCCURRED ON A FEW OCCASIONS BUT THE TREND APPEARS LOW WHEN COMPARED TO THE INSTALL BASE. A REVIEW OF PRODUCTION RECORDS INDICATED TO MANUFACTURING ANOMALIES AT THE TIME OF MANUFACTURING. A ROOT CAUSE INVESTIGATION WAS COMPLETED AND CONCLUDED THAT THE ROOT CAUSE FOR THIS EVENT APPEARS TO BE THAT THE ELECTRONIC CONTACT PLATE HAS SHORTED. THEN THE CONTACT PLATE SENT OUT WRONG SIGNALS TO THE PCB, WHICH LED TO UNCOMMANDED MOVEMENT ON THE DEVICE. ELECTRICAL COMPONENTS ARE SUPPLIED IN APPROPRIATE ENVIRONMENT AND ARE CHECKED AT THE INPUT CONTROL. HOWEVER, THERE IS AN OFF CHANCE THAT AN ELECTRICAL COMPONENT FAILS AFTER LIMITED USE. THE INTENDED USE CONDITIONS FOR THE DEVICE ARE EXPLAINED IN THE INSTRUCTIONS FOR USE (IFU) AS SUPPLIED WITH THE DEVICE (04.GA.05_6GB): "DAILY OBLIGATION: DRY THE CONTACT PLATE WITH A DRY AND LEAN RAG." A RISK EVALUATION WAS PERFORMED AND RESULTED IN AN ACCEPTABLE RISK LEVEL. WHEN THE MALFUNCTION WAS DETECTED THE PRODUCT WAS TAKEN OUT OF USE ACCORDING TO THE IFU INSTRUCTIONS: "CUSTOMER OBLIGATIONS SHALL BE CARRIED OUT BY QUALIFIED PERSONNEL FOLLOWING THE INSTRUCTIONS IN THIS MANUAL. IF SOMETHING LOOKS WRONG WITH THE PRODUCT OR DEVIATES FROM NORMAL FUNCTION, CONTACT IMMEDIATELY YOUR LOCAL ARJO SERVICE FOR SUPPORT." WE SUGGESTS REPLACEMENT OF THE FOLLOWING COMPONENTS EXCEPT FOR THOSE ALREADY REPLACED: CONTACT PLATE ON THE ENTROY LIFTS LIFT ARM AND THE LIFT PCB. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES IN THE ABUNDANCE OF CAUTION. WE HAVE FOUND THE DEVICE WAS NOT TO SPECIFICATION AT THE TIME OF THE EVENT, AND THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, BUT THE LIFT WAS NOT BEING USED FOR PT HANDLING AT THE TIME AND THERE WERE NO ADVERSE OUTCOME TO ANY PERSON.

    Description of Event or Problem · 1

    THE ENTROY LIFT IS A POOL LIFT FOR ASSISTED TRANSFER IN AND OUT OF THE POOL. IT CAN BE EQUIPPED WITH EITHER CHAIR OR STRETCHER. IT WAS REPORTED THAT THE BACKREST OF THE ENTROY STRETCHER MOVED UNCOMMANDEDLY. AN ARJOHUNTLEIGH SERVICE TECHNICIAN VISITED SITE TO INSPECT THE DEVICE AND FOUND THAT THE CONTROL FUNCTIONS FOR RAISING AND LOWERING THE BACKREST WAS OPERATING IN REVERSE AND THE LIFT CORD ASSEMBLY HAD REVERSED ITSELF THROUGH OVERRIDING THE UPPER LIMIT SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117714 ENTROY HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB GAB1000-01-GB

    Patients

    Seq Age Sex Outcome Treatment
    1