BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRETCHER CHAIR

    MDR report key: 2081768 · Received April 13, 2011

    Report

    Report Number
    1831750-2011-03510
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA USER FACILITY MEDWATCH: AN ICU PT WAS PLACED IN THE STRETCHER ON A CHAIR SEATING POSITION. THE PT WITH VELCRO SAFETY STRAP INTACT AND THE SIDERAILS WERE UP. UPON NURSE ENTERING THE ROOM, THE PT WAS FOUND LAYING FACE DOWN ON THE FLOOR. MOST PRESSURE NOTED TO BE TO PT'S RIGHT FOREHEAD AND RIGHT SHOULDER. CHAIR WAS NOTED TO BE IN AN EJECT LIKE POSITION AND THE VELCRO STRAPS WERE INTACT. THE PT'S NECK AND SPINE WERE STABILIZED AND PT PLACED ON HER BACK. VITAL SIGNS STABLE. NO LOSS OF CONSCIOUSNESS, THE PT WAS ALERT AND AWAKE. PT WAS UNABLE TO COMMUNICATE WHAT HAPPENED. PT COMPLAINED OF PAIN OF HEAD, NECK AND RIGHT SHOULDER. PT WAS UNABLE TO FULLY RAISE HER RIGHT ARM. DR PERFORMED A FULL NEUROLOGICAL ASSESSMENT. PT WAS SENT FOR CT SCAN OF CERVICAL SPINE AND HEAD. NO INJURY WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRETCHER CHAIR HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 5050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR