BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 6134503 · Received November 30, 2016

    Report

    Report Number
    3003768277-2016-00114
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 14, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DUE TO NOT FOLLOWING MRI SAFETY STANDARDS BY BRINGING A NON MR COMPATIBLE WHEELCHAIR INTO THE MR EXAMINATION ROOM. IT IS KNOWN THAT NO MAGNETIC MATERIALS SHOULD BE BROUGHT INTO THE EXAMINATION ROOM. THE SAFETY DIRECTIONS AS PRESENTED IN THE INSTRUCTION FOR USE ALREADY CONTAIN WARNINGS ON THIS MATTER.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT AN MR TECHNICIAN WAS INJURED. WHEN THE MR EXAMINATION WAS COMPLETED, A MR TECHNICIAN AND THE PATIENT´S WIFE CAME IN THE EXAMINATION ROOM WITH A WHEEL CHAIR TO HELP REMOVE THE PATIENT. THE WHEEL CHAIR WAS ATTRACTED TO THE MAGNET. THE PATIENT DID NOT GET INJURED BUT THE MR TECHNICIAN TRIED TO REMOVE THE CHAIR WITH TWO HANDS AND ONE OF THEM BECAME TRAPPED WHEREBY TWO FINGERS GOT INJURED. THE INJURIES REQUIRE SURGICAL INTERVENTION; ONE OF THE FINGERS HAD A BROKEN MIDDLE PHALANX AND THE SECOND SUFFERED A DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786578 ACHIEVA 1.5T NOVA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other