BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADFIX

    MDR report key: 1813658 · Received August 19, 2010

    Report

    Report Number
    9710332-2010-00001
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    IYE
    PMA / PMN Number
    K030439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    HEADFIX IS A UNIQUE VACUUM ACTIVATED HEAD FRAME USED DURING PRECISE RADIATION TREATMENT DELIVERY, PROVIDING A HIGHLY ACCURATE AND RELIABLE NON-INVASIVE IMMOBILIZATION AND REPOSITIONING DEVICE. THE HEADFIX IS POSITIONED ON THE TREATMENT TABLE BY A PIN-HOLE CONNECTION BETWEEN THE HEADFIX BASEPLATE AND THE ADAPTER (OR EXTENSION). SO THE HEADFIX BASEPLATE HAS TWO HOLES THAT FIT ON TWO PROTRUDING PINS OF THE ADAPTER (OR EXTENSION). THE HEADFIX BASEPLATE IS NOT SCREWED DOWN TO THE ADAPTER TO ALLOW TO COMPENSATE FOR ROLL AND PITCH WITH THE HEADFIX LEVELLING SCREWS OF THE HEADFIX BASEPLATE. WITH SUCH NON-INVASIVE SYSTEMS (AND IT IS THE SAME FOR HEADFIX) THE PATIENT IS IMMOBILIZED WITH RESPECT TO THE TABLE INDEXING SYSTEM, BUT THE SYSTEM CANNOT AVOID MOVEMENT IF THE PATIENT TRIES TO GET UP, AS IN THIS CASE, THE PATIENT LOOSENED THE SYSTEM FROM THE TABLE ATTACHMENT WITH THEIR MOVEMENT. THOSE TYPES OF SYSTEMS REQUIRE THE COOPERATION OF THE PATIENT TO BE EFFECTIVE AND AS ACCURATE AS POSSIBLE. IT IS NOT DESIGNATED A FULL FIXATION AND RESTRAINT DEVICE. CURRENT REGULATIONS CLEARLY DEMAND FOR SAFETY MECHANISMS: CAMERAS NEED TO BE INSTALLED TO CONTROL (VISUAL) THE PATIENT DURING TREATMENT. THIS VISUAL CONTROL OF THE PATIENT IS CLEARLY STATED IN THE RESPECTIVE IEC REGULATION FOR SUCH LINEAR ACCELERATORS AND THEREFORE CAMERAS ARE INSTALLED. SO, PERSONNEL ARE ABLE TO STOP TREATMENT AT ANY TIME IF SOMETHING HAPPENS.

    Description of Event or Problem · 1

    A PATIENT UNDER TREATMENT COUGHED WHICH LIFTED THE TOP FRAME PIECE OFF OF THE PEGS AND IT DID NOT RETURN TO ITS ORIGINAL POSITION. NO PATIENT MISTREATMENT OCCURRED DURING THIS EVENT, BUT RECURRENCE OF THIS TYPE OF EVENT MAY CONTRIBUTE TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEADFIX HEADFIX BASE PLATE P2 IYE MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other