BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1241223 · Received November 9, 2008

    Report

    Report Number
    1241223
    Event Type
    Malfunction
    Date Received
    November 9, 2008
    Date of Event
    September 19, 2008
    Report Date
    November 9, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S RIGHT HAND INCURRED A TEAR/CUT FROM THE FLUOROSCOPY TABLE SIDE RAIL (METAL TRACK ON THE SIDE OF THE FLUORO TABLE) DURING PROCEDURE. THE PART OF TABLE CAUSING THE INCIDENT WAS PADDED WITH BLANKETS, BUT PATIENT MOVEMENT DURING PROCEDURE RESULTED IN A TEAR/CUT. WITH PERMISSION FROM THE REPORTER, THE FOLLOWING INFO WAS MOVED FROM ANOTHER PART OF THE REPORT:THE NURSE INVOLVED STATED THIS PATIENT HAD PAPER THIN SKIN AND SO WAS AT HIGHER RISK. THE STAFF IN THIS (ERCP) ROOM ROUTINELY PAD THE SIDERAIL WITH BATH BLANKETS, AS EXTRA PRECAUTION FOR ANY PATIENT(WHERE AN ARM CAN FALL BETWEEN THE SIDE RAIL AND THE TABLE). IT IS NOT NECESSARILY A FAULTY DESIGN; BUT THERE EXISTS THE POSSIBILITY OF A PATIENT'S ARM/SKIN COMING IN CONTACT WITH METAL IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK X-RAY SYSTEM, FLUOROSCOPY JAA SIEMENS MEDICAL SOLUTIONS USA, INC UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR