BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 1220264 · Received October 31, 2008

    Report

    Report Number
    9611530-2008-00062
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 30, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR EXAMINED THE DEVICE AND FOUND WHITE EGG SHELL PAINT MARKS ON THE SIDE RAILS. THERE WAS A CRACK IN THE PAINT ON THE RIGHT SIDE RAIL WHERE IT WAS BENT. THERE WERE SOME SMALL HOLES THROUGHOUT THE PAD, AND THE BATTERY COVER WAS CRACKED. THE SIDE RAILS WERE BENT, PREVENTING THE SIDE BRACKETS FROM LOCKING INTO PLACE. THE REST OF THE UNIT FUNCTION TESTED CORRECTLY. THE CUSTOMER STATED THEY HAD RE-BENT THE SIDE RAIL BACK INTO PLACE OVER A PERIOD OF TIME. THE EVENT HAS BEEN RECREATED; THE RIGHT SIDE RAIL WILL NOT LOCK. THE MAINTENANCE SUPERVISOR AT THE SITE ALSO STATED THAT THEY NEED HANDS-ON TRAINING FOR THEIR STAFF ON ALL UNITS. MANY OTHER SHOWER TROLLEYS WERE IMPROPERLY BEING USED BY LOADING ITEMS SUCH AS TV'S, ETC. CAUSING DAMAGE TO UNIT PADS. THE MANUFACTURER CONCLUDES THE ROOT CAUSE OF THE EVENT IS BOTH USER ERROR AND LACK OF MAINTENANCE. THE PRODUCT HAS BEEN IN NEED OF SERVICE/TECHNICAL CHECK FOR QUITE SOME TIME (FOUND IN BAD CONDITION); A DEFECT PRODUCT WAS USED. BOTH SAFETY CATCHES MUST LOCK. THE OPERATING AND PRODUCT CARE INSTRUCTIONS STATE, UNDER THE CHAPTER MAINTENANCE, TO WEEKLY EXAMINE THE SHOWER TROLLEY FOR DAMAGE AND PERFORM AN ANNUAL EXCHANGE OF THE SAFETY CATCH. THIS MOST LIKELY HAS NOT BEEN DONE, ACCORDING TO THE STATEMENTS DESCRIBING THE BAD CONDITION OF THE DEVICE. THE MANUFACTURER RECOMMENDS LIFT OPERATORS BE RETRAINED REGARDING THE VARIOUS FUNCTIONS AND USE OF THE PRODUCT. DAMAGED AND WORN PARTS HAVE TO BE REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE BRACKETS FOR THE RAILS AT THE HEAD AND FOOT OF THE TROLLEY WERE BENT AND THAT A PT DROP HAD OCCURRED. SAFETY STAFF WAS INVESTIGATING THE INCIDENT.

    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