BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB STRETCHER

    MDR report key: 2955563 · Received February 11, 2013

    Report

    Report Number
    0001831750-2013-00982
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE RAIL COVERS ON THIS CUB CRIB WERE DAMAGED. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE UPPER AND LOWER FOOT END RAIL COVERS WERE CRACKED WITH EXPOSED SHARP EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58921 CUB PEDIATRIC CRIB STRETCHER BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1