BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 357659 · Received October 24, 2001

    Report

    Report Number
    MW1023179
    Event Type
    Other
    Date Received
    October 24, 2001
    Report Date
    October 22, 2001
    Manufacturer
    MDT DIAGNOSIS CO
    Product Code
    FTD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXAM LIGHT FELL ON DR DURING DELIVERY OF BABY. THE LIGHT WAS POSITIONED FOR DELIVERY, THEN FELL, STRIKING THE DR ON THE BACK, KNOCKING THEM DOWN. DR CONTINUED WITH THE DELIVERY, THEN WENT TO THE ER AFTER THE PT WAS STABILIZED. THIS MOBILE EXAM LIGHT IS DESIGNED WITH A "U" SHAPED BASE. THE LAMP HEAD HAS APPROX 45 DEGREES OF TRAVEL TO KEEP IT CENTERED OVER THE BASE FOR STABILITY. INSPECTION OF THE LIGHT BY MEDICAL MAINTENANCE REVEALED A SHEARED STOP PIN, WHICH HAD ALLOWED THE LAMP HEAD TO BE POSITIONED IN A POSITION THAT WAS NOT BALANCED OVER ITS BASE. ALL EXAM LIGHTS IN THE FACILITY WERE INSPECTED AND 6 OUT OF 10 WERE FOUND TO HAVE SHEARED STOP PINS. RPTR NOTIFIED THE MFR AND WAS TOLD THAT THEY HAD NEVER HEARD OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47729 * MOBILE EXAMINATION LIGHT FTD MDT DIAGNOSIS CO 2312M *
    47730 * MOBILE EXAMINATION LIGHT FTD MDT DIAGNOSIS CO 2412M *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other