BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 6043868 · Received October 20, 2016

    Report

    Report Number
    1825014-2016-00009
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    August 26, 2016
    Report Date
    August 31, 2016
    Manufacturer
    IHB OPERATIONS B.V.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED ON (B)(6) 2016 VIA MAIL. HOWEVER, WE THEN RECEIVED A MESSAGE FROM THE FDA THAT ALL REPORTS THEN HAD TO BE SUBMITTED ELECTRONICALLY. IT TOOK A FEW WEEKS TO GET OUR PRODUCTION ACCOUNT SET UP AND RUNNING WHICH CAUSED THE DELAY IN REPORTING.

    Description of Event or Problem · 1

    THE IV POLES HOLDING PUMPS FELL OFF ITS BED MOUNT WITH A PATIENT CONNECTED TO IT BY AN ARTERIAL LINE AMONG OTHER THINGS. THERE WERE NO INJURIES THAT WE ARE AWARE OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694212 SKYTRON IV TRANSPORT FQO IHB OPERATIONS B.V. EZ-GO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention