MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC 1.5T INFINITY TWINSPEED 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); Full thickness (Third Degree) Burn (2696); No Code Available (3191)

Event Date 05/26/2020

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, through medwatch # mw5094776, that a patient sustained a full thickness burn to the left lateral thigh following a mr examination of the lumbar spine.The customer states that the patient was padded but he believes that the pad may have moved during the examination.The burn was initially diagnosed as a 2nd degree burn the size of a nickle, however the patient was sent to wound care for follow-up where after monitoring the wound for several weeks, the diagnosis was changed to a full thickness burn measuring 1.4cm x 2cm x 0.1 cm that required multiple debridement procedures.

Manufacturer Narrative

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: 1.5T INFINITY TWINSPEED 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: 10280497
• MDR Text Key: 199039006
• Report Number: 2183553-2020-00008
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K012200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 130