BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 2172642 · Received July 20, 2011

    Report

    Report Number
    3003768277-2011-00442
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (CONCLUSIONS)- IT IS KNOWN THAT THERE IS A SMALL SPACE BETWEEN THE PATIENT TABLE AND THE MAGNET COVER WHERE THE FINGER PINCHING MAY OCCUR. THIS POTENTIAL HAZARD WAS IDENTIFIED DURING DESIGN OF THE SCANNER AND NOTED IN THE RISK ANALYSIS. TO REDUCE THE PROBABILITY OF HARM, A SWITCH PLATE BETWEEN THE TABLE TOP AND FACADE WAS DESIGNED TO STOP THE PATIENT TABLE SHOULD SOMETHING (E.G. A FINGER) COME IN CONTACT WITH IT. FURTHER, ARM RESTS ARE PROVIDED WITH EACH SCANNER, WHICH KEEP THE ARMS INSIDE THE OUTER SIDES OF THE TABLE TOP. TRAINING IS PROVIDED AT INSTALLATION OF THE SCANNER THAT INCLUDES THE USE OF ARM RESTS AND THE INSTRUCTIONS FOR USE. THIS TRAINING EMPHASIZES THE IMPORTANCE OF THE USER ENSURING THAT THE PATIENT'S ARMS DO NOT HANG OVER THE EDGE OF THE TABLE TOP CREATING A HAZARDOUS SITUATION. IF THE INSTRUCTIONS FOR USE ARE FOLLOWED CORRECTLY AND THE ARM REST IS USED THAT IS DELIVERED WITH THE SYSTEM, NO FINGER PINCHING EVENTS ARE LIKELY TO OCCUR. IN THIS SPECIFIC CASE, THE ARM RESTS DELIVERED WITH THE SYSTEM WERE NOT USED. THE SWITCH PLATE WAS ACTIVATED AND STOPPED THE TABLE MOVEMENT. HOWEVER THIS ALONE WOULD NOT PREVENT THE FINGER PINCHING, WHICH IN THIS CASE, REQUIRED MEDICAL INTERVENTION. IN FUTURE SITUATIONS MAKE SURE THAT THE PATIENT'S HANDS ARE INSIDE THE TABLE AREA BEFORE MOVING THE TABLE AND COMMUNICATE TO THE PATIENT THAT THE TABLE IS GOING TO MOVE.

    Description of Event or Problem · 1

    THE PATIENT WAS POSITIONED SUPINE WITH THE FEET FIRST INTO THE SCANNER. WHILE MOVING THE TABLE TOP INTO THE MAGNET THE PATIENT'S RIGHT FINGER GOT CAUGHT BETWEEN THE TABLE TOP AND THE MAGNET BORE COVERS. THIS RESULTED IN A SERIOUS INJURY NEEDING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NOVA LNH PHILIPS HEALTHCARE 781196

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other