BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD/NECK 26 STRETCH OBS1/00

    MDR report key: 3020315 · Received March 25, 2013

    Report

    Report Number
    0001831750-2013-02488
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT END BRAKES WOULD NOT ENGAGE DUE TO A BENT BRAKE ADJUSTER AND MISSING ROLLERS. THE BRAKES ON THE HEAD END FUNCTIONED TO SPECIFICATION. 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
    121575 HEAD/NECK 26 STRETCH OBS1/00 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1