BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMA STRETCHER

    MDR report key: 2141412 · Received June 1, 2011

    Report

    Report Number
    1831750-2011-05361
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE STRETCHER HAS NOW BEEN TAKEN OUT OF COMMISSION UNTIL IT IS INSPECTED AND REPAIRED. THE CUSTOMER IS UNSURE OF THE SERIAL NUMBER AND DOES NOT KNOW WHERE EXACTLY THE NUT AND WASHER CAME FROM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A NUT AND WASHER HAD FALLEN OUT FROM UNDERNEATH THE STRETCHER DURING TRANSIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAUMA STRETCHER HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1037 NA

    Patients

    Seq Age Sex Outcome Treatment
    1