BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 6102109 · Received November 15, 2016

    Report

    Report Number
    3003768277-2016-00106
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION AND INVESTIGATION PERFORMED NO MALFUNCTION OF THE MR DEVICE WAS OBSERVED. THE FINGER SWITCH PLATE WAS TESTED ON SITE, AND FOUND TO BE WORKING. IT WAS HOWEVER REPORTED THAT IN THIS CASE NO ARM SUPPORTS WERE USED TO ENSURE THAT THE PATIENT'S EXTREMITIES REMAINED ON THE TABLETOP. ARM SUPPORTS ARE DELIVERED WITH EACH MRI SYSTEM. THESE ARM SUPPORTS CAN BE USED TO AVOID FINGER PINCHING.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A PATIENT'S FINGER GOT INJURED WHILE BEING MOVED INTO THE BORE OF THE MR SYSTEM. THE FINGER OF THE PATIENT WAS PINCHED BETWEEN THE TABLE TOP AND THE MAGNET BORE COVER, RESULTING INTO A FRACTURE OF THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752515 ACHIEVA 1.5T NOVA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other