BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACU REC. MODEL

    MDR report key: 3021563 · Received March 26, 2013

    Report

    Report Number
    0001831750-2013-02500
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 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 BRAKES HAD MALFUNCTIONED DUE TO MALFUNCTIONED BRAKE SCHIMS AND PADS. 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
    124312 PACU REC. MODEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1