MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT; 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); Burn, Thermal (2530); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: 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 undergoing an mri of the right shoulder sustained a burn with blisters to the left arm.The patient was not padded to prevent contact to the sides of the magnet bore or to prevent skin to skin contact.It was reported that the patient will receive skin grafting for treatment of the injury.

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: 8866352
• MDR Text Key: 153442175
• Report Number: 2183553-2019-00015
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

2 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 100