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

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

Event Date 08/03/2019

Event Type  Injury  

Manufacturer Narrative

There are no device identification numbers known at this time.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 undergoing an mri exam of the knee sustained a burn with blisters to the left ankle.The burn was reported to have worsened and was treated by surgical debridement at a different hospital.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices 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: 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 53188
• MDR Report Key: 8983084
• MDR Text Key: 157340318
• Report Number: 2183553-2019-00022
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• 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: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR