MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Necrosis (1971); Full thickness (Third Degree) Burn (2696)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

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 patient sustained a burn to the right elbow during her mr examination of the left shoulder.The patient was padded to prevent contact with the magnet bore, however the technologist indicated that when she removed the patient from the bore, she could see that the pad had shifted during the exam allowing the patient's elbow to be in contact with the bore.The burn was described as a 4 cm full thickness burn to the right elbow.The patient was examined by the radiology nurse in the department and then sent to the emergency department where she was given silvadene cream for the burn and referred to wound care.During treatment by wound care, tissue in the area of the burn became necrotic and the patient will now be scheduled for debridement of the wound.

Manufacturer Narrative

Ge healthcare's investigation has been completed.The mr scanner was operating within specifications and determined to be operating normally when checked by the ge healthcare 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 the 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.

• Brand Name: GE 1.5T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha WI
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 7282709
• MDR Text Key: 100443765
• Report Number: 2183553-2018-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UDI_NOT_REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 100