BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 26 OBS 10/04

    MDR report key: 3073404 · Received April 23, 2013

    Report

    Report Number
    0001831750-2013-03680
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, IT WAS REPORTED THAT THE SIDE RAIL COULD BECOME UNLATCHED DURING USE DUE TO A MISSING COMPRESSION SPRING. THIS WAS REPORTED IN ERROR. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE EXTENSION SPRINGS WERE MISSING, CAUSING THE SIDERAILS TO BE DIFFICULT TO MOVE. THIS ISSUE IS NOT LIKELY TO RESULT IN SERIOUS INJURY OR DEATH AS THE SIDE RAIL COULD STILL REMAIN LATCHED AND COULD BE UNLATCHED, IF NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD BECOME UNLATCHED DURING USE DUE TO MISSING COMPRESSION SPRING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD BECOME UNLATCHED DURING USE DUE TO MISSING COMPRESSION SPRING. 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
    174903 ADVANTAGE SERIES 26 OBS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1