BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 3.0 T

    MDR report key: 7348699 · Received March 19, 2018

    Report

    Report Number
    3003768277-2018-00022
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 15, 2018
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K043147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    SERVICE PERSONNEL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOR 3.0T INTERA / ACHIEVA SYSTEMS 2 TYPES OF QUAD BODY COILS ARE AVAILABLE: THE RF BODY COIL (45356701308X) SYSTEM FOR 3.0T TITAN MAGNETS AND RF BODY COIL (45356714026X) FOR 3.0 T REX MAGNETS. THE RF BODY COIL (45356701308X) SYSTEM FOR 3.0T TITAN MAGNETS IS MAGNETIC AND THE MAGNET MUST BE RAMPED DOWN PRIOR TO REPLACEMENT. THE SYSTEM INVOLVED IS AN ACHIEVA 3.0T SYSTEM WITH A REX MAGNET, SO THE RF BODY COIL (45356714026X) FOR 3.0 T REX MAGNETS SHOULD HAVE BEEN ORDERED. THE INCORRECT RF BODY COIL (45356701308X) FOR A 3.0T TITAN MAGNET WAS ORDERED BY MISTAKE. THE PERSON ORDERING THE RF BODY COIL WAS NOT AWARE THAT THERE ARE 2 TYPES OF THE RF BODY COILS AVAILABLE FOR THIS 3.0T MR SYSTEM. THE ONE LISTED ON TOP OF THE ELECTRONIC SERVICE PART LIST FOR THIS MR SYSTEM WAS ORDERED WHICH WAS THE INCORRECT TYPE. THIS WAS NOT RECOGNIZED BY THE FSE'S ON SITE RESULTING IN THE INCIDENT AS DESCRIBED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    FOR 3.0T INTERA / ACHIEVA SYSTEMS 2 TYPES OF QUAD BODY COILS ARE AVAILABLE: THE RF BODY COIL (45356701308X) SYSTEM FOR 3.0T TITAN MAGNETS AND RF BODY COIL (45356714026X) FOR 3.0 T REX MAGNETS. THE RF BODY COIL (45356701308X) SYSTEM FOR 3.0T TITAN MAGNETS IS MAGNETIC AND THE MAGNET MUST BE RAMPED DOWN PRIOR TO REPLACEMENT. THE SYSTEM INVOLVED IS AN ACHIEVA 3.0T SYSTEM WITH A REX MAGNET, SO THE RF BODY COIL (45356714026X) FOR 3.0 T REX MAGNETS SHOULD HAVE BEEN ORDERED. THE INCORRECT RF BODY COIL (45356701308X) FOR A 3.0T TITAN MAGNET WAS ORDERED BY MISTAKE. THE PERSON ORDERING THE RF BODY COIL WAS NOT AWARE THAT THERE ARE 2 TYPES OF THE RF BODY COILS AVAILABLE FOR THIS 3.0T MR SYSTEM. THE ONE LISTED ON TOP OF THE ELECTRONIC SERVICE PART LIST FOR THIS MR SYSTEM WAS ORDERED WHICH WAS THE INCORRECT TYPE. THIS WAS NOT RECOGNIZED BY THE FSE'S ON SITE RESULTING IN THE INCIDENT AS DESCRIBED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    DURING CORRECTIVE MAINTENANCE, REPLACEMENT OF THE QUADRATURE BODY COIL (QBC), A PHILIPS FIELD SERVICE ENGINEER WAS SERIOUSLY INJURED. THE ENGINEERS INVOLVED IN THE SERVICE ACTION WERE NOT AWARE THAT THE PART THEY WERE TO REPLACE (QBC) WAS MAGNETIC. AS A RESULT THE QBC WAS ATTRACTED TO THE MAGNET DURING REPLACEMENT. THIS CAUSED A SERIOUS INJURY TO THE HAND OF ONE OF THE ENGINEERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193535 ACHIEVA 3.0 T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other