BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 26 OBS 10/25/04

    MDR report key: 3162274 · Received June 11, 2013

    Report

    Report Number
    0001831750-2013-05276
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEAD END BRAKES WERE NOT WORKING DUE TO A BROKEN BRAKE ADJUSTER. ALSO, DAMAGED CASTERS THAT COULD RESULT IN REDUCED BRAKE FORCE WERE FOUND. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263190 RENAISSANCE 26 OBS 10/25/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1