BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 1022203 · Received March 26, 2008

    Report

    Report Number
    9611530-2008-00012
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 6, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPLOYEES STATED THAT, BEFORE THE INCIDENT TOOK PLACE, THERE WAS NO REASON TO EXPECT SOMETHING LIKE THIS MALFUNCTION. AN ARJO INVESTIGATOR EXAMINED THE DEVICE AND FOUND IT IN A BAD CONDITION. THE DEVICE HAD BEEN REMOVED FROM USE AND PUT INTO THE CELLAR. THE SIDE SUPPORT HAD COMPLETELY BROKEN OFF. THE MFR CONCLUDES THE ROOT CAUSE OF THIS INCIDENT IS MOST LIKELY THE STAFF ROLLED THE PT AGAINST THE SIDE RAIL WHEN DRESSING THE RESIDENT. IT IS STATED IN THE OPERATING AND PRODUCT CARE INSTRUCTIONS (OPI): "THIS EQUIPMENT IS INTENDED FOR BATHING AND SHOWERING RESIDENTS. ALL OTHER USES MUCH BE AVOIDED." "WHEN RAISING THE SIDE SUPPORT, MAKE SURE THE TWO CATCHES SNAP INTO PLACE." "MAKE SURE THAT THE PT IS LYING IN THE MIDDLE OF THE STRETCHER. IF THE PT'S POSITION IS OFF-CENTER, THE DEVICE MAY TIP OVER, CAUSING SERIOUS INJURY TO THE PT AND OPERATOR." IT IS CLEAR THE DEVICE WAS IN NEED OF A SERVICE/TECHNICAL CHECK FOR QUITE SOME TIME. IN THE OPI, UNDER THE CHAPTER MAINTENANCE, USERS ARE INSTRUCTED TO EXAMINE THE PRODUCT WEEKLY FOR DAMAGE AND, ON AN ANNUAL BASIS, EXCHANGE THE SAFETY CATCH. THIS HAS MOST LIKELY NOT BEEN DONE, ACCORDING TO THE STATEMENT OF THE BAD CONDITION OF THE DEVICE. THE MFR RECOMMENDS RETRAINING OF THE CUSTOMER, ESPECIALLY REGARDING THE REQUIREMENTS OF THE OPI. ALL DAMAGED AND WORN PARTS SHOULD BE REPLACED BEFORE THE DEVICE IS RETURNED TO USE.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT WAS ON THE SHOWER TROLLEY AND BEING AIDED WITH SHOWERING BY TWO EMPLOYEES. THE RESIDENT HAD JUST BEEN SHOWERED AND DRIVEN FROM THE SHOWER ROOM INTO THE SITTING/BEDROOM. THE RESIDENT WAS BEING DRESSED IN THE SITTING/BEDROOM WHILE ON THE SHOWER TROLLEY. DURING TURNING OF THE RESIDENT, AN EMPLOYEE HEARD A CRACK, AT WHICH TIME THE SUPPORT CAME LOOSE AND THE RESIDENT FELL ONTO THE FLOOR. THE RESIDENT SUSTAINED A SCRATCH ON THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO SHOWER TROLLEY FPO ARJO HOSPITAL EQUIPMENT AB BABXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1