BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRAULIC GURNEY WITH STRETCHER AND MATTRESS

    MDR report key: 2093552 · Received April 5, 2011

    Report

    Report Number
    2020676-2011-00003
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 5, 2011
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS EXEMPT FROM 510(K) UNDER 21 CFR PART 880. MANUFACTURER IS AWAITING RETURN OF PARTS FOR EVALUATION TO DETERMINE ROOT CAUSE. AWAITING FURTHER INFORMATION ON REPORTED USER INJURIES. WILL PROVIDE UPDATE OF DEVICE EVALUATION AND USER INJURY WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DIFFICULTY IN MOVING STRETCHER IN AND OUT OF HYPER BARIC CHAMBER WITH PATIENT ON STRETCHER. COMPLAINT OF INJURY ASSOCIATED WITH EFFORT REQUIRED TO MOVE THE STRETCHER WITH PATIENT. THE STRETCHER IS A COMPONENT OF THE HYDRAULIC GURNEY. THE PATIENT RESTS ON A MATTRESS PLACED OVER THE STRETCHER PLATE. THE STRETCHER PLATE WHEELS RIDES ON RAILS THAT ALLOWS THE STRETCHER PLATE AND PATIENT TO BE MOVED INTO AND OUT OF A HYPERBARIC CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAULIC GURNEY WITH STRETCHER AND MATTRESS HYDRAULIC GURNEY FPO SECHRIST INDUSTRIES, INC. 21465-01

    Patients

    Seq Age Sex Outcome Treatment
    1