BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRASCAN TABLE

    MDR report key: 2718726 · Received August 21, 2012

    Report

    Report Number
    1932056-2012-00005
    Date Received
    August 21, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 21, 2012
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO REMEDIAL ACTION WILL BE TAKEN. THE END USER DID NOT HEED TWO DIFFERENT SAFETY WARNINGS THAT APPEAR IN THE MANUAL AND ON THE PRODUCT ITSELF. FIRST, THERE IS A PRODUCT WARNING WHICH STATES NOT TO LEAVE THE PT UNATTENDED WHILE IN USE (THIS IS AN IMAGING SURFACE NOT A PT BED). SECOND, THERE IS A SAFETY WARNING TO NOT PLACE FULL BODY WEIGHT ON THE FOOT END OF THE PRODUCT AS IT COULD LEAD TO TIPPING OF THE DEVICE. MEDICAL POSITIONING, INC SHALL UTILIZE ITS CUSTOMER COMPLAINT PROCEDURE TO CONTINUE MONITORING FOR ADD'L EVENTS WHICH COULD CONSTITUTE A TREND.

    Description of Event or Problem · 1

    THE PT WAS INSTRUCTED TO CHANGE INTO A GOWN AND TO GET ON THE TABLE AND A STAFF MEMBER WOULD COME BACK TO DO THE PROCEDURE. THE PT WAS THEN LEFT ALONE. WHILE THIS PT WAS UNATTENDED SHE FELL. SHE HAD SKIN BREAK ON HER ELBOW AND COMPLAINED OF HIP PAIN. SHE WAS IMMEDIATELY TAKEN TO THE EMERGENCY DEPT. X-RAYS WERE NEGATIVE FOR ANY BROKEN BONES AND ONLY A SHOULDER SPRAIN WAS DESCRIBED IN THE EMERGENCY DEPT DISCHARGE SUMMARY. THE PT WAS THEN RELEASED TO GO HOME ON THAT SAME DAY. A STAFF MEMBER INTERVIEWED THE PT WHILE SHE WAS IN THE EMERGENCY ROOM DEPT ON (B)(6) 2012, AND SHE EXPLAINED THAT SHE HAD SCOOTED BACKWARDS AND TRIED TO LIFT HER BUTTOCKS UP TO GET ONTO THE TABLET AT THE FOOT SECTION. SHE REPORTS THAT THE FOOT SECTION GAVE WAY AND SHE FELL. THE FOOT SECTION IS DESIGNED TO FOLD UP AND DOWN. THE PRODUCT WAS NOT BROKEN OR DAMAGED IN ANY WAY TO CAUSE THE EVENT. THE HOSP STAFF ATTEMPTED TO RECREATE THE EVENT SEVERAL DIFFERENT WAYS AND WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASCAN TABLE ULTRASCAN TABLE LGX MEDICAL POSITIONING, INC. 8094

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other