MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Thermal Decomposition of Device (1071); Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).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 following an intra-operative mri procedure involving a brain tumor surgery, the patient had a burn injury to the left scalp which was in direct contact with a medtronic nipt (non-invasive patient tracker) for the duration of the mri scan.The medtronic tracker had visible thermal damage, and the burn injury occurred directly underneath the point of contact between the tracker and the scalp.The patient was diagnosed with a 2.5cm by 1.8cm full thickness burn.The patient was treated with first aid and bandage changes every other day.The patient was referred to plastic surgery, but subsequently cancelled that appointment.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.A gehc field engineer completed system testing and verified that the mri scanner was operating normally and within performance specifications.The root cause was determined to be operator error related to the use of a 3rd party medtronic axiem non-invasive patient tracker (nipt) during the patient mri scan.Per discussion with the user, the medtronic mr conditions for use were not strictly followed during this procedure, resulting in an rf burn to the patient.Per our gehc operator manual, the user must ensure the safe use of mr conditional devices during patient scans.Users should consult the device manufacturers instructions and safety guidelines.No further actions are planned by gehc.Medtronic has been notified of the patient event involving their product.

• 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
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 8434084
• MDR Text Key: 139251289
• Report Number: 2183553-2019-00002
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2019
• 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: 67 YR
• Patient Weight: 86