BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLIANCE AIR 40/64/UCT

    MDR report key: 7735366 · Received July 31, 2018

    Report

    Report Number
    1525965-2018-00415
    Event Type
    Injury
    Date Received
    July 31, 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, WHILE AT THE SITE, THAT AN OPERATOR TRIPPED AND FELL IN 2017 ON THE VELCRO TABLE STRAP THAT IS USED TO RESTRAIN PATIENTS ON THE INGENUITY CT SYSTEM RESULTING IN A KNEE AND SHOULDER INJURY. IN THIS CASE, THERE WAS NO IMPACT OR INJURY TO A PATIENT. HOWEVER, THE OPERATOR OF THE SYSTEM SUSTAINED AN INJURY TO THEIR KNEE AND SHOULDER AFTER THEY TRIPPED AND FELL ON THE VELCRO TABLE STRAP. THE OPERATOR CONTINUED TO WORK, BUT DID RECEIVE PHYSICAL THERAPY FOR THE INJURIES. WITH THE TABLE AT ITS LOWEST POSITION, THE VELCRO STRAPS USED FOR RESTRAINING PATIENTS REST ON THE FLOOR. AFTER CLINICAL USE, THE STRAPS WERE NOT PLACED BACK UP ON THE TABLE AND THE OPERATOR TRIPPED OVER THEM. THE STRAPS ARE THE PHILIPS PATIENT RESTRAINT STRAPS, AND IN THIS CASE, WERE THE LONGER STRAPS THAT ARE USED FOR LARGER PATIENTS. THE CUSTOMER STATED THAT THE STRAPS ARE TOO LONG. THERE WAS NO MALFUNCTION OF THE SYSTEM; THE SYSTEM WORKS AS SPECIFIED. THE CAUSE OF THE INJURY WAS DUE TO USE ERROR BY THE OPERATOR. THE OPERATOR REMOVED THE STRAPS FROM THE TABLE WHEN NOT IN USE. THE SYSTEM IS OPERATIONAL AND IN CLINICAL USE.

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED, THIS ISSUE IS BEING CHANGED TO A SERIOUS INJURY. UPON FURTHER INVESTIGATION, THE CLINICAL APPLICATIONS SPECIALIST (CAS) WAS INFORMED THAT THE OPERATOR WENT TO PHYSICAL THERAPY FOLLOWING THEIR FALL AND KNEE INJURY. BASED ON THE FURTHER INFORMATION, THIS HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    NOTE: 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 NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THAT AN OPERATOR TRIPPED AND FELL ON THE VELCRO STRAP USED TO RESTRAIN THE PATIENT, WHICH RESULTED IN THE OPERATOR INJURING THEIR KNEE. A PHILIPS CLINICAL APPLICATIONS SPECIALIST (CAS) CONFIRMED THAT NO MEDICAL INTERVENTION WAS REQUIRED, AND THE OPERATOR DID NOT NEED TO TAKE ANY TIME OFF WORK. THE 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
    577571 BRILLIANCE AIR 40/64/UCT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR