BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLIANCE AIR 40/64/UCT

    MDR report key: 7714021 · Received July 24, 2018

    Report

    Report Number
    1525965-2018-00414
    Event Type
    Injury
    Date Received
    July 24, 2018
    Report Date
    July 12, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED TO A PHILIPS APPLICATIONS SPECIALIST (AS), WHILE AT THE SITE, AN OPERATOR TRIPPED AND FELL IN 2017 ON THE VELCRO STRAP THAT IS USED TO RESTRAIN THE PATIENT ON THE INGENUITY CT SYSTEM RESULTING IN AN ELBOW INJURY. IN THIS CASE, THERE WAS NO IMPACT TO A PATIENT. HOWEVER, THE AS CONFIRMED THAT THE OPERATOR FRACTURED THEIR ELBOW AND WAS UNABLE TO WORK FOR 6 WEEKS. WHEN THE TABLE IS AT ITS LOWEST POSITION, THE VELCRO STRAPS, USED FOR RESTRAINING PATIENTS, REST ON THE FLOOR. AFTER THE PATIENT WAS REMOVED FROM THE SYSTEM, THE VELCRO STRAPS WERE NOT FOLDED BACK ON THE TABLETOP. AS A RESULT, THE OPERATOR TRIPPED ON THE STRAP AND FELL. THE STRAPS ARE PHILIPS PATIENT RESTRAINT STRAPS, AND IN THIS CASE, THE LONGER STRAP USED FOR LARGER PATIENTS WAS USED. THE CUSTOMER CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE SYSTEM. THE CAUSE OF THE INJURY WAS DUE TO USE ERROR BY THE OPERATOR. THE SYSTEM DID, HOWEVER, CONTRIBUTE TO THE INJURY. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS AN ALLEGATION OF A SERIOUS INJURY. THE CUSTOMER REPORTED THAT AN OPERATOR TRIPPED AND FELL ON THE VELCRO STRAP THAT IS USED TO RESTRAIN THE PATIENT ON AN INGENUITY CT SYSTEM RESULTING IN AN INJURY. THE OPERATOR BROKE THEIR ELBOW. PHILIPS CLINICAL APPLICATIONS SPECIALIST (CAS) CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE SYSTEM. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557799 BRILLIANCE AIR 40/64/UCT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR