BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO, BASIC & SHOWER TROLLEY

    MDR report key: 1647996 · Received March 30, 2010

    Report

    Report Number
    9611530-2010-00016
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 8, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING ACCORDING TO (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, ARJO INC, (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 03/08/2010: WHILE SHOWERING CLIENT WENT SITTING UNCONTROLLED. CLIENT HAS THEN SLIPPED IN THE DIRECTION OF THE FOOT END. THE CONCERTO HAS TIPPED TO ONE SIDE AND THE HELPER HAS CAUGHT CLIENT. THE CONCERTO IS SLIGHTLY IN THE "ANTI-TRENDELENBURG" FOR A BETTER DRAINAGE OF THE WATER. CONCERTO HAS BEEN PUT 'OUT OF FUNCTION'. AJOHUNTLEIGH SERVICE ENGINEER WILL INSPECT CONCERTO AT 10-03-2010, AND PUT IT INTO USE. AJOHUNTLEIGH PRACTICE SPECIALIST WILL CONTACT THE USER GROUP TO ADVISE CORRECT USE OF THE CONCERTO. (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 BAB10007-01

    Patients

    Seq Age Sex Outcome Treatment
    1