BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HDX 3T

    MDR report key: 1153240 · Received September 5, 2008

    Report

    Report Number
    2183553-2008-00036
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) WAS DISPATCHED TO THE SITE AND CONFIRMED THAT THERE WAS A MAGNET WARNING SIGN ON THE MAGNET ROOM DOOR. THE FE ALSO VERIFIED THAT THE MR SYSTEM WAS OPERATIONAL. FURTHER INTERVIEW WITH THE SITE REVEALED THAT THE OXYGEN TANK WAS PAINTED AS A NON-FERROUS CONTAINER.

    Description of Event or Problem · 1

    THE SITE REPORTED AN INCIDENT WHERE A TECHNOLOGIST WAS TAKING A FERROUS OXYGEN TANK INTO THE MR SCAN ROOM. UPON ENTRY, THE OXYGEN TANK WAS PULLED TOWARD THE MAGNET. THE TECHNOLOGIST HOLDING THE TANK WAS ABLE TO GUIDE IT SO THAT IT HIT THE FRONT OF THE MAGNET AND TABLE INSTEAD OF GOING INTO THE BORE. AT THIS TIME, A PATIENT WAS LYING PRONE, FEET FIRST ON THE TABLE. THE OXYGEN TANK CONTACTED THE PATIENT. THE SITE HAD NO INFORMATION ABOUT THE EXACT POINT OF CONTACT WITH THE PATIENT. A PHYSICIAN EXAMINED THE PATIENT AND INITIALLY DETERMINED HER TO BE FINE. DURING A FOLLOW-UP BY THE SITE, THE PATIENT COMPLAINED OF RIGHT SHOULDER PAIN AFTER RETURNING HOME. THE PATIENT VISITED HER PHYSICIAN AND A RIGHT SHOULDER X-RAY EXAM WAS TAKEN. ALTHOUGH NO SHOULDER INJURY WAS DETECTED, THE PHYSICIAN FOUND 3 CRACKED RIBS AND A PNEUMOTHORAX. THE SITE INDICATED THAT THE PT'S RECOVERY WAS MONITORED BY HER PHYSICIAN BUT NO OTHER TREATMENT WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDX 3T LNH GE MEDICAL SYSTEMS, LLC 2358531 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other