BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMA STRETCHER

    MDR report key: 2191366 · Received July 28, 2011

    Report

    Report Number
    1831750-2011-07784
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - FOWLER. ADDITIONAL COMMENTS: THIS USER FACILITY SERVES AS THE HEALTH CARE PROVIDER FOR ONE OF THE STATE PRISONS. AS A RESULT, IT HAS BEEN REPORTED THAT PATIENTS INTENTIONALLY DAMAGE VARIOUS DEVICE COMPONENTS WITH UNRESTRAINED APPENDAGES. ADDITIONALLY, PATIENTS ARE REGULARLY RESTRAINED IN MANNERS THAT CONFLICT WITH THE DEVICE'S INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CORNER COVERS WERE BROKEN, THE FOWLER CYLINDER WAS LEAKING FLUID AND COULD NOT BE LOWERED. THE CUSTOMER COULD NOT DETERMINE WHETHER THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAUMA STRETCHER HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1