BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBI (TM) TABLE

    MDR report key: 4898830 · Received July 2, 2015

    Report

    Report Number
    1932056-2015-00001
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MPI WORKED WITH FORBES HOSPITAL TO DETERMINE THE CAUSE OF THE UNEXPECTED TABLE MOVEMENT. THE COMPANY WAS ABLE TO ISOLATE THE CAUSE TO THE HAND CONTROL BY RECREATING THE INCIDENT AT ITS FACILITY. AS THIS PARTICULAR TABLE HAS BEEN IN USE SINCE (B)(6) 2011, THE COMPANY BELIEVES THE HAND CONTROL WAS DAMAGED FROM USER ABUSE, AND HAS SENT THE HAND CONTROL TO THE SUPPLIER, (B)(4), FOR FURTHER EVALUATION. MPI HAS MANUFACTURED THE DBI TABLE SINCE 2003 AND THIS IS THE FIRST SUCH OCCURRENCE OF THIS INCIDENT. THE OCCURRENCE RATING FOR THIS INCIDENT FOR THE DBI TABLES SOLD SINCE 2007 IS (B)(4), OR REMOTE. IF THE INCIDENT WERE TO OCCUR AGAIN, THE HARM WOULD BE MINOR (CONTUSION OR RIPPING OF THE SKIN). AS SUCH, MPI HAS DETERMINED THAT NO FIELD ACTION IS NECESSARY AS THIS EVENT CAN BE PREVENTED WITH USER CARE OF THE HAND CONTROL.

    Description of Event or Problem · 1

    THE PATIENT WAS ON A DECUBITUS BREAST IMAGING (DBI) TABLE WITH HER LEFT BREAST IN COMPRESSION. THE TABLE MOVED UNEXPECTEDLY, AT A NORMAL RATE OF SPEED, APPROXIMATELY 9-12 INCHES, PULLING THE PATIENT'S BREAST OUT OF COMPRESSION. THERE WAS NO DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT, ONLY DISCOMFORT AND POSSIBLY BRUISING FROM THE BREAST BEING PULLED FROM COMPRESSION. THE USER FACILITY, FORBES HOSPITAL, CONFIRMED THAT THE PATIENT WAS NOT INJURED. HOWEVER, MEDICAL POSITIONING, INC. (MPI) HAS DETERMINED THAT A RECURRENCE OF THE EVENT COULD LEAD TO A CONTUSION OR RIPPING OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433104 DBI (TM) TABLE BREAST IMAGING TABLE LGX MEDICAL POSITIONING, INC. 7407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other