MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC NUCLEAR MAGNETIC RESONANCE IMAGING; DISCOVERY MR750 3.0T

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Udi not required 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 with a history of diabetes underwent an mri of the lumbar spine and complained of feeling hot, especially in the arms.Initially, blankets had been placed to isolate the patient from the bore wall.The blankets were exchanged with pads after continuous complaints of being warm.Two days later, while being seen in urgent care, an rf burn was noted on the patient's arm.Wound care evaluated the patient and assessed the burn as partial thickness.The burn was lanced and treated with medihoney and foam dressing.Although treated, the burn progressed to a full thickness wound.

Manufacturer Narrative

Ge healthcare's investigation has been completed.The mr system 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 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: NUCLEAR MAGNETIC RESONANCE IMAGING
• Type of Device: DISCOVERY MR750 3.0T
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 8128791
• MDR Text Key: 129190091
• Report Number: 2183553-2018-00019
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/04/2019
• 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: 75 YR
• Patient Weight: 127