BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 1171356 · Received September 17, 2008

    Report

    Report Number
    9611530-2008-00053
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR HAS EXAMINED THE DEVICE AND FOUND MISSING SCREWS THROUGHOUT THE UNIT STRETCHER AND A SIGNIFICANT AMOUNT OF RUST. THERE WAS CRACKED FIBERGLASS THROUGHOUT THE STRETCHER AND A BROKEN LOCK ON THE RIGHT RAIL. THE UNIT COULD NOT BE FUNCTION TESTED DUE TO ITS CONDITION. THE UNIT IS COMPLETELY WORN. THE ROOT CAUSE FOR THE INCIDENT IS LACK OF MAINTENANCE. THE LOCKING HOOK THAT WAS BROKEN SHOULD BE REPLACED ONCE A YEAR; DEFECT PRODUCT WAS USED. THE PRODUCT IS 15 YEARS OLD AND, EVEN THOUGH NO EXPECTED LIFETIME IS STATED IN THE 1993 USER MANUAL, IT IS POINTED OUT THAT THE LIFETIME IS DEPENDING ON SUFFICIENT MAINTENANCE. IN THE CURRENT OPERATING AND PRODUCT MAINTENANCE INSTRUCTIONS MANUAL (OPI), IT IS STATED UNDER THE CHAPTER TITLED "SERVICE AND MAINTENANCE TO WEEKLY EXAMINE THE TROLLEY FOR DAMAGES. OBVIOUSLY THE PRODUCT WAS IN NEED FOR A SERVICE/TECHNICAL CHECK FOR QUITE SOME TIME. IN ITS CURRENT STATE, THE DEVICE IS DANGEROUS TO USE. THE MANUFACTURER STRONGLY RECOMMENDS IT BE REPLACED. AT A MINIMUM, WORN/DAMAGED PARTS HAVE TO BE REPLACED AND LIFT OPERATORS RETRAINED, ESPECIALLY REGARDING REGULAR INSPECTION AND MAINTENANCE OF THE EQUIPMENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE STAFF MEMBER WAS GIVING A SHOWER TO THE INJURED PARTY IN THE SHOWER TROLLEY. AFTER COMPLETING THE SHOWER, THE STAFF MEMBER TURNED THE RESIDENT ONTO THE STOMACH AND PROCEEDED WITH DRYING THE RESIDENT. THE SHOWER TROLLEY STRETCHER THEN CAME DETACHED FROM THE LEFT SIDE. THE RESIDENT FELL OUT OF THE SHOWER TROLLEY ON TO THE BATHROOM TILE FLOOR. THE RESIDENT SUSTAINED INJURIES TO THE SHOULDER AND ARM. THE COMPLETE INJURY DESCRIPTION WAS NOT PROVIDED. THE RESIDENT RECEIVED SOME MEDICAL TREATMENT AND WAS RELEASED THE SAME DAY FROM THE ER. MFR. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other