BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AKRON STREAMLINE CONTINENTAL A

    MDR report key: 1882878 · Received October 15, 2010

    Report

    Report Number
    3000140091-2010-00001
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 16, 2010
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD - AKRON
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE COMPONENT IS EN ROUTE TO ARJOHUNTLEIGH FOR INVESTIGATION. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSIO ASKED THE PATIENT TO LIE DOWN ON HIS BACK ON THE AKRON STREAMLINE COUCH; THE PATIENT LAY DOWN AND THEN WAS ASKED TO SLIDE DOWN A FEW INCHES TO FREE HIS SHOULDER FROM THE PILLOW. AT THIS POINT, THE BACKREST COLLAPSED DOWN TO A 7 O'CLOCK POSITION, AND THE PATIENT THEN STARTED TO SLIDE BACKWARD TOWARDS THE COLLAPSED BACKREST. HIS LEGS AND HIPS STARTED TO RAISE IN THE AIR AS HE WAS FALLING BACKWARDS OFF THE COUCH; HIS BODY TWISTED AND THE PATIENT CAME OFF THE COUCH IN A BACKWARDS ROLL MOVEMENT TO THE LEFT AND LANDED ON THE FLOOR. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKRON STREAMLINE CONTINENTAL A REHAB COUCH FQO HUNTLEIGH HEALTHCARE LTD - AKRON 2231A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other