BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA 1.5 ECHO

    MDR report key: 2041166 · Received March 30, 2011

    Report

    Report Number
    2183553-2011-00017
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 30, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K962061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS REQUESTED BUT WAS NOT PROVIDED BY THE HOSPITAL. THE SITE DECLINED TO RELEASE THE EXACT DATE OF THE EVENT. IT IS BELIEVED THAT THE EVENT OCCURRED ON OR BEFORE (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED A BURN DURING A LUMBAR MAGNETIC RESONANCE (MR) SCAN. THE MR MANAGER CONFIRMED THAT THE PT SUSTAINED A SCAB ON THEIR RIGHT LEG. THE SIZE OF THE SCAB IS NOT KNOWN. THE PT WAS UNDER SEDATION DURING THE SCAN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE NECESSARY INFO REQUIRED TO INVESTIGATE THIS INCIDENT. NO DETAILS REGARDING THE PT'S MEDICAL TREATMENT WERE PROVIDED. THE HOSPITAL INDICATED THAT THEY WERE NOT SURE IF THE MR SCAN CAUSED OR CONTRIBUTED TO THE PT'S INJURY. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA 1.5 ECHO MAGNETIC RESONANCE IMAGING SYSTEM LNH GE MEDICAL SYSTEMS, LLC 2138300-29

    Patients

    Seq Age Sex Outcome Treatment
    1 Other