BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEM N.A. TABLE TILT

    MDR report key: 2401075 · Received December 30, 2011

    Report

    Report Number
    MW5023709
    Event Type
    Injury
    Date Received
    December 30, 2011
    Date of Event
    December 5, 2011
    Report Date
    December 30, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS N.A.
    Product Code
    IXR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS A (B)(6) WHO PRESENTED TO THE ED WITH COMPLAINTS OF NAUSEA, VOMITING AND DIARRHEA FOR 4 DAYS. SHE WAS RECENTLY DIAGNOSED WITH ESOPHAGEAL CANCER IN (B)(6) 2011 AND WAS STATUS POST 3 ROUNDS OF RADIATION AND CHEMOTHERAPY. HER HOSPITALIZATION WAS COMPLICATED BY SEVERE PANCYTOPENIA SECONDARY TO HER RADIATION/CHEMO TREATMENTS. THE PT ALSO HAD A HISTORY OF ATRIAL FIBRILLATION WITH RVR. ON (B)(6) 2011, SHE WAS PLACED ON A PHILIPS TABLE TILT WITH AN ATTACHED FLUOROSCOPY UNIT IN PREPARATION FOR A TUNNEL DIALYSIS CATHETER. SHE HAD A SAFETY STRAP PLACED ACROSS HER LOWER TORSO/LEGS. WHILE STAFF WAS STILL PREPARING THE CASE, THE PT ROLLED OFF THE TABLE AND FELL FACE FIRST ONTO THE FLOOR. A TRAUMA TEAM WAS CALLED AND RESULTANT FILMS INDICATED AN ACUTE FRACTURE OF THE BONY NASAL SEPTUM AND A C6 NONDISPLACED FRACTURE. WITHIN SEVERAL HRS OF THE FALL, SHE SHOWED SIGNS OF A MASSIVE EMBOLIC STROKE THAT RESULTED IN LEFT SIDED PARALYSIS AND COMPLETE UNRESPONSIVENESS. THE FAMILY MADE HER COMFORT CARE AND SHE EXPIRED ON (B)(6) 2011. THE PHILIPS TABLE WAS RECENTLY INSTALLED AND THERE WAS NO ORIENTATION OR INSTRUCTION ON THE ATTACHMENT FOR THE LOWER EXTREMITY BELT THAT WAS PART OF THE TABLE. HOSPITAL IMMEDIATELY INQUIRED ABOUT ANY UPPER BODY SAFETY FEATURES AND PHILLIPS IDENTIFIED AND INSTALLED A "SAFETY RATCHET" TO HOLD A BELT THAT COULD BE PURCHASED FOR AN ADD'L FEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEM N.A. TABLE TILT TABLE TILT IXR PHILIPS MEDICAL SYSTEMS N.A. NCVA791 XPER TABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| O| R