BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB- HYD BASE

    MDR report key: 2150212 · Received June 10, 2011

    Report

    Report Number
    1831750-2011-05812
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN OUTER SPRING IN HANDLE ASSEMBLY. BROKEN HANDLE GUARD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT SIDE RAIL RELEASE HANDLE AND GUARD IS BROKEN AND UNABLE TO LOCK IN THE UPRIGHT POSITION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUB PEDIATRIC CRIB- HYD BASE BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL FL19H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK