BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLIANCE AIR 40/64/UCT

    MDR report key: 7714026 · Received July 24, 2018

    Report

    Report Number
    1525965-2018-00413
    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
    Product Problem
    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, THAT AN OPERATOR TRIPPED AND FELL IN 2014 AFTER THEIR SHOE BECAME STUCK IN THE VELCRO OF THE STRAPS THAT WERE USED TO RESTRAIN A PATIENT ON THE INGENUITY CT SYSTEM RESULTING IN AN INJURY TO THE OPERATOR'S HAND AND WRIST. THE STRAPS WERE LEFT ON THE FLOOR. THERE WAS NO PATIENT IMPACT PER A PHILIPS APPLICATION SPECIALIST (AS). HOWEVER, THE AS CONFIRMED THAT THE OPERATOR SUSTAINED A HAND AND WRIST INJURY FROM THE FALL ON THE VELCRO STRAPS. AS A RESULT, THE OPERATOR WAS UNABLE TO WORK FOR SEVERAL DAYS. 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 UP ONTO THE TABLETOP. AS A RESULT, THE OPERATOR TRIPPED AND FELL AFTER THEIR SHOE BECAME STUCK IN THE VELCRO OF THE STRAP. THE STRAPS ARE PHILIPS PATIENT RESTRAINT STRAPS, AND IN THIS CASE, WERE LONGER WHICH ARE USED FOR LARGER PATIENTS. THE OPERATOR INJURED THEIR HAND AND WRIST. THE OPERATOR RECEIVED MEDICAL INTERVENTION; HOWEVER, THERE WERE NO FRACTURES. 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 OPERATOR REMOVED THE STRAPS WHEN NOT IN CLINICAL USE. THE SYSTEM IS OPERATIONAL AND IN CLINICAL USE. 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

    INTERNAL CROSS REFERENCE: COMPLAINT PR#: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS AN ALLEGATION OF SERIOUS INJURY. THE CUSTOMER REPORTED THAT AN OPERATOR TRIPPED AND FELL AFTER THEIR SHOELACE BECAME STUCK ON THE VELCRO OF THE STRAP USED TO RESTRAIN A PATIENT ON THE INGENUITY CT SYSTEM RESULTING IN AN INJURY TO THE OPERATOR'S SHOULDER. PHYSICAL THERAPY WAS NEEDED. 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
    557796 BRILLIANCE AIR 40/64/UCT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR