BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHOBED DUAL

    MDR report key: 3608606 · Received July 30, 2013

    Report

    Report Number
    1932056-2013-00003
    Event Type
    Other
    Date Received
    July 30, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 25, 2013
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE DEVICE WAS NOT DIRECTLY INSPECTED BY MPI, A PHYSICAL INSPECTION WAS PERFORMED BY (B)(6) MEDICAL CENTER STAFF. THE INSPECTION FOUND NO SHARP EDGES ON THE PRODUCT. IT WAS ALSO NOTED THAT THE ECHOBED WAS WORKING PROPERLY. THE EVENT COULD NOT BE DUPLICATED (A CUT CAUSED BY CONTACT WITH THE IV POLE HOLDER). A REVIEW OF THE MPI COMPLAINT LOGS REVEALED THAT PREVIOUS TO THIS INCIDENT NO ONE HAS BEEN INJURED AS A RESULT OF CONTACT WITH THE IV POLE HOLDER. THE COMPANY WILL CONTINUE TO MONITOR COMPLAINT AND OTHER SOURCES OF QUALITY DATA FOR EVIDENCE OF A TREND; HOWEVER, IT APPEARS THAT THIS IS A UNIQUE INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MPI BECAME AWARE OF AN ADVERSE EVENT WHICH TOOK PLACE ON ONE OF MEDICAL POSITIONING, INC.'S (MPI) IMAGING TABLES. BELOW IS THE DESCRIPTION FROM THE MDR FILED BY (B)(6) MEDICAL CENTER: "EVENT DESCRIPTION: THE PT COMPLETED HER ECHOCARDIOGRAM AND WHILE SITTING UP SHE SCRAPED THE BACK OF HER RIGHT LEG WHILE PREPARING TO MOVE FROM THE ECHO BED BACK TO HER WHEEL CHAIR. PT STATED THAT SHE HIT HER LEG. FLUID CONTAINING BLOOD WAS SEEN DRIPPING FROM HER UPPER CALF. PT SCRAPED THE BACK OF HER LEG ON SMALL 'POLE HOLDER' LOCATED ON LOWER RIGHT HALF OF THE BED WHEN DISMOUNTING. POLE HOLDERS HAVE BEEN REMOVED FROM BOTH OF THE ECHO BEDS. ONE BED HAS BEEN QUARANTINED BY THE DEPARTMENT; THE OTHER IS BEING HELD BY QUALITY AND SAFETY. THE ECHO BED THAT WAS USED IS WORKING PROPERLY. WE HAVE BEEN USING TWO ECHOBEDS IN OUR DEPARTMENT FOR SEVERAL YEARS WITHOUT INCIDENT. THE TOP AND SIDES OF THE ECHOBED ARE IN GOOD SHAPE. THERE ARE NO SHARP EDGES ON THE LOWER 1/2 OF THE ECHOBED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356925 ECHOBED DUAL TABLE, EXAMINATION, MEDICAL, POWERED LGX MEDICAL POSITIONING, INC. 1222

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention PT REQUIRED A PROCEDURE AS A RESULT OF THE,| INCIDENT