BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5T ACHIEVA PULSAR

    MDR report key: 4949115 · Received July 29, 2015

    Report

    Report Number
    3003768277-2015-00061
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 24, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K030520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION IT IS CONCLUDED THAT THE INJURY AS SUSTAINED BY THE PATIENT IS CAUSED BY A USER ERROR. DURING MOVEMENT OF THE TABLE INTO THE BORE THE PATIENT SUDDENLY GRABBED HOLD OF THE EDGE OF THE TABLE TOP. THIS LED TO THE RIGHT RING FINGER OF THE PATIENT BEING PINCHED BETWEEN THE TABLETOP AND THE BORE COVERS. WITHIN THE INSTRUCTIONS FOR USE THERE ARE WARNINGS RELATED TO MOVING THE PATIENT INTO THE BORE. DURING MOVEMENT THE OPERATOR SHOULD ALWAYS CHECK THE PATIENT'S HANDS AND MAKE SURE THERE ARE NO CABLES OR EXTREMITIES POSITIONED SUCH THAT THEY CAN BE CAUGHT. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A PATIENT INJURED THE RING FINGER OF THE RIGHT HAND AFTER BEING MOVED INTO THE BORE OF THE MR SYSTEM. THE PATIENT'S RING FINGER GOT PINCHED BETWEEN THE MAGNET COVER AND TABLE TOP. THE PATIENT'S RIGHT RING FINGER WAS CUT AND SIX STITCHES WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494435 INTERA 1.5T ACHIEVA PULSAR SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781171

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other