BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPU

    MDR report key: 1412289 · Received June 28, 2009

    Report

    Report Number
    1412289
    Event Type
    Malfunction
    Date Received
    June 28, 2009
    Date of Event
    May 18, 2009
    Report Date
    June 28, 2009
    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

    AN INJURY WAS NOTICED BY A PATIENT CARE TECH ASSISTANT. THIS WAS NOTICED AFTER THE PROCEDURE. THERE WAS BLOOD ON THE BLANKET. INITIALLY WE THOUGHT THAT THE IV PULLED OUT AFTER WE MOVED THE PATIENT FROM EXAM TABLE TO STRETCHER. EXAMINATION OF THE RIGHT HAND SHOWED ABOUT A 1X1 CM SKIN BREAK/ABRASION ON THE CENTER BACK OF RIGHT HAND WHICH MIGHT HAVE BEEN CAUSED BY MOVING THE PATIENT. THE HAND MAY HAVE GOTTEN CAUGHT IN THE GAP BETWEEN THE TABLE AND STRETCHER. THE SIDE BAR OF THE X-RAY EXAM TABLE HAS A SHARP CORNER. USUALLY WE COVER IT WITH A BLANKET TO PREVENT SUCH AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPU X-RAY SYSTEM, CATH/ANGIO JAA SIEMENS MEDICAL SOLUTIONS USA, INC. 05904433 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR