BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 29 OBS10/04

    MDR report key: 3023721 · Received March 27, 2013

    Report

    Report Number
    0001831750-2013-02604
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL LATCH WAS BROKEN AND COULD RESULT IN THE SIDE RAIL BECOMING UNLATCHED. CUSTOMER HAS ATTEMPTED TO REPAIR THE UNIT AND HAS REFUSED TO ALLOW THE STRYKER TECHNICIAN TO REPAIR THE UNIT. 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
    125891 ADVANTAGE SERIES 29 OBS10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1501

    Patients

    Seq Age Sex Outcome Treatment
    1