BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLERO

    MDR report key: 870530 · Received September 25, 2006

    Report

    Report Number
    9611530-2006-00038
    Event Type
    Malfunction
    Date Received
    September 25, 2006
    Date of Event
    September 18, 2006
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR EXAMINED THE DEVICE AND FOUND THE UNIT IN GOOD CONDITION WITH SOME CORROSION TO THE STRETCHER FRAME AND ONE CHASSIS LEG. THERE IS NO SIDE SUPPORT WITH THE SYSTEM, (IT IS AN OPTIONAL ACCESSORY). THE SAFETY BELTS WERE NEW; THE MATRESS PADS WERE FOUND SLIGHTLY WORN WITH MINOR CRACKING. THE SYSTEM WAS WORKING TO MFR SPEC. IN A REPORT FROM THE SITE, IT WAS STATED THE SAFETY BELTS WERE MISSING AT THE TIME OF THE INCIDENT. THIS IS ALL THE INFO THE FACILITY WOULD RELEASE. ACCORDING TO THE PRODUCT, OPERATING AND PRODUCT CARE INSTRUCTIONS, BOTH STRAPS ARE TO BE USED WHILE THE RESIDENT IS ON THE LIFT. THE MFR RECOMMENDS RETRAINING OF LIFT OPERATORS, ESPECIALLY REGARDING THE PROPER USE OF THE SAFETY BELTS. THE SAFETY BELTS HAVE BEEN PURCHASED AND RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT FELL FROM THE SHOWER STRETCHER ONTO THE FLOOR AND WAS TAKEN TO THE EMERGENCY ROOM FOR A CHECK UP. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLERO LIFT BATH TROLLEY FSA ARJO HOSPITAL EQUIPMENT AB CEBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *