BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITION DYNAMICS - OPTIMA

    MDR report key: 461012 · Received May 15, 2003

    Report

    Report Number
    1931654-2003-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2003
    Date of Event
    April 17, 2003
    Report Date
    May 5, 2003
    Manufacturer
    MEDICAL INDUSTRIES AMERICA, INC.
    Product Code
    KNN
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EVENT PERTAINS TO THE MOUNTING SYSTEM OF A POSITION DYNAMICS OPTIMA WHEELCHAIR TILT SEATING SYSTEM. THE MOUNTING SYSTEM CONNECTS THE SEATING SYSTEM TO THE WHEEL BASE. IN ADDITION, THE MOUNTING WEIGHT TO THE WHEEL BASE. THE PATIENT WAS SITTING IN A POSITION DYNAMICS OPTIMA WHEELCHAIR SEATING SYSTEM. THE PATIENT FELT THE CHAIR LEAN AND DISCONNECT FROM THE BASE. THE PATIENT MANUALLY SUPPORTED THE WEIGHT AND REMAINED IN A SITTING POSITION UNTIL HELP ARRIVED. THE PATIENT WAS NOT INJURED. THE MALFUNCTION IS ISOLATED TO A LIFT STYLE MOUNTING KIT OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSITION DYNAMICS - OPTIMA WHEELCHAIR REHAB TILT AND RECLINE SEATING SYSTEM KNN MEDICAL INDUSTRIES AMERICA, INC. TILT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other