Device Problems
Unexpected Therapeutic Results (1631); Use of Device Problem (1670)
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Patient Problems
Burn(s) (1757); Skin Discoloration (2074); Numbness (2415); Skin Inflammation (2443)
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Event Date 04/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).There are no additional device identification numbers.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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Event Description
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It was reported that a male patient was having an mri of the lumbar spine under anesthesia.Due to the patient's size, ge recommended pads were not used.The patient presented with an area of redness the size of a baseball on his left forearm with the inner core appearing dark brown.The patient complained of numbness in his hand and fingers.He was seen by the hospital's wound care team and debridement of the wound was necessary.The patient continues to have dressing changes.
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Manufacturer Narrative
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The investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices, including the redundant rf power monitors, were functional when checked by the gehc field engineer.The root cause of the injury was determined to be inadequate patient padding for the mri procedure.The operator documentation describes the appropriate safety measures for padding patients for mr exams.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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Search Alerts/Recalls
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