BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29

    MDR report key: 2143570 · Received June 2, 2011

    Report

    Report Number
    1831750-2011-05418
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT BOTH THE HEAD AND FOOT-END SLOTTED PINS WERE BROKEN, ALLOWING THER BRAKE/STEER PEDALS TO SPIN AROUND THE BRAKE ROD. THIS WAS NOT ALLOWING THE STRETCHER TO GO INTO STEER OR BRAKE. IT IS UNK IF THERE WAS PT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAISSANCE 29 HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1