BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRBI- HYD BASE

    MDR report key: 2891349 · Received November 29, 2012

    Report

    Report Number
    1831750-2012-12351
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    FLEXTRONICS EMS CANADA
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY STRYKER SERVICE TECH DON JOHNSON THAT THE CUSTOMER ALLEGED THAT THE BRAKES COULD NOT BE ENGAGED. THE CUSTOMER DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUB PEDIATRIC CRBI- HYD BASE PEDIATRIC OPEN HOSPITAL BED FMS FLEXTRONICS EMS CANADA FL19H NA

    Patients

    Seq Age Sex Outcome Treatment
    1