MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Skin Discoloration (2074); Numbness (2415); Skin Inflammation (2443)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: SIGNA ARCHITECT
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8653642
• MDR Text Key: 146487349
• Report Number: 2183553-2019-00011
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K163331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 200