BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO + BASIC

    MDR report key: 3110542 · Received April 4, 2013

    Report

    Report Number
    9611530-2013-00031
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Product Code
    ILJ
    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). THIS IS DECIDED TO BE A 'MALFUNCTION' TYPE OF EVENT NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE FOUND A NUMBER OF PREVIOUS CASES WITH SIMILAR FAULT DESCRIPTION (PATIENT FALLS FROM THE DEVICE), WHICH WERE FOUND TO MAINLY RELATED TO USE AND MAINTENANCE ERROR. (B)(4). THE DEVICE WAS UP TO SPECIFICATION AND WAS USED FOR PATIENT TRANSFER WHEN THE PROBLEM WAS DETECTED, AND BECAUSE OF THIS IT CAUSED OR CONTRIBUTED TO THE EVENT. FROM OUR EVALUATION IT APPEARS AN USE ERROR MIGHT BE SUGGESTED TO HAVE CAUSED THE COMPLAINT: FAILURE TO CHECK THE PATIENT POSITION ON THE DEVICE DURING USE WHICH IS CLEARLY STATED IN THE INSTRUCTION FOR USE (04.BA.05/1US.CA. DATED OCTOBER 2006): 'WARNING! IF RESIDENT'S POSITION IS NOT IN THE MIDDLE THE CONCERTO/BASIC MAY TIP OVER CAUSING SERIOUS INJURY TO THE RESIDENT AND THE CAREGIVER." WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE INSTRUCTIONS FOR USE SAFETY WARNINGS ARE FOLLOWED THERE WILL BE NO PATIENT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    IMPORTER REF NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137977 CONCERTO + BASIC SHOWER SYSTEMS ILJ

    Patients

    Seq Age Sex Outcome Treatment
    1