Unique identifier: udi not required.There are no additional device identification numbers at this time, requested but not yet received.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.
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It was reported that a patient underwent bilateral shoulder exams.The patient was padded between the bore and arms, however due to involuntary movement, the pads may have shifted.The patient complained of elbow pain and was reported to present with redness on the skin of the left elbow.The patient was seen by plastic surgery who diagnosed the area on the elbow as pressure ulcer versus an rf burn.Treatment was provided by plastic surgery for the pressure ulcers.Information provided by the customer states the patient was in the scanner for two hours.
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H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications when checked by the gehc field engineer.The patient was padded between the bore and arms, however, due to involuntary movement, the pads may have shifted.The patient's pre-existing conditions contributed to the severity.Based on the information received, this incident occurred due to moving and positioning of the patient.The mr operator has the final responsibility for the use and placement of non-conductive mr compatible padding and preparation of the patient, prior to starting the mr exam procedure.No further actions are planned by gehc.
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