BEUDAMED
    FDA Adverse Event Death Summary report: N

    TOSHIBA

    MDR report key: 1998207 · Received February 22, 2011

    Report

    Report Number
    2020563-2011-00002
    Event Type
    Death
    Date Received
    February 22, 2011
    Date of Event
    March 29, 2010
    Report Date
    March 29, 2010
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    KXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS IS A FOREIGN INCIDENT FOUND DURING AN INTERNAL AUDIT. WHEN THE HOSPITAL TELEPHONED TO INFORM TOSHIBA MEDICAL SYSTEMS (B)(4) OF THE INCIDENT, THEY INQUIRED IF RAILS WERE AVAILABLE TO PREVENT A PATIENT FROM FALLING OFF. THE HOSPITAL WAS ADVISED THERE ARE ACCESSORIES AVAILABLE FOR THIS PURPOSE. ON (B)(6) 2010, THE HOSPITAL REQUESTED FURTHER DETAILS OF (RESTRAINT) ACCESSORIES AND RELEVANT PROCEDURES ON SAFE USE. AN APPOINTMENT WAS MADE FOR (B)(6) 2010. DURING THE MEETING BETWEEN (B)(4) RELEVANT STAFF AND RELEVANT HOSPITAL STAFF, A REVIEW OF THE VARIOUS ACCESSORIES FOR PATIENT RESTRAINT AND ASSOCIATED INSTRUCTIONS IN THE OPERATION MANUAL WAS CONDUCTED. IT WAS CONFIRMED THAT SOME ACCESSORIES WERE NOT USED (TABLE EXTENSION AND VELCRO BANDS). (B)(4) REITERATED THAT PATIENT AIDS PROVIDED WERE INCLUDED TO ASSIST IN PATIENT CARE AND THESE WERE ALL DEMONSTRATED DURING APPLICATIONS TRAINING. THE HOSPITAL INDICATED THAT THEY WOULD REVIEW THE RELEVANT PROCESSES. RESULTS OF THE INVESTIGATION BY THE MANUFACTURER INDICATES THAT THE DEVICE MET THE SPECIFICATIONS AND DID NOT CONTRIBUTE TO THE INCIDENT. IT WAS CONCLUDED THAT THERE SEEMED TO HAVE BEEN A POSSIBLE LAPSE IN PATIENT CARE. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED. (B)(4) WAS INFORMED BY THE HOSPITAL THAT THE PATIENT WAS INJURED ON (B)(6) 2010. THEN PATIENT DIED ON (B)(6) 2010.

    Description of Event or Problem · 1

    ON (B)(6) 2010 AFTER AN X-RAY EXAMINATION WAS COMPLETED, THE PATIENT FELL FROM THE X-RAY COUCH AFTER A POSSIBLE TEMPORARY LAPSE OF PATIENT CARE. THE PATIENT SUSTAINED AN UNDISPLACED FRACTURE OF THE ODONTOID PEG (NOT FRACTURED THROUGH SO THE PATIENT WAS NOT PARALYZED), BRUISING AND CUTS ON THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA CATHERIZATION TABLE KXJ TOSHIBA MEDICAL SYSTEMS CORPORATION CAT-870B

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death