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

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problems Partial thickness (Second Degree) Burn (2694); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

(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 after an mri of the thoracic spine, a female patient presented with a 2nd degree partial thickness burn on her breast.The patient was padded properly but the robe that the patient was wearing may have had conductive material in the seam causing this issue.The patient underwent burn therapy which included a skin graft.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.No systemic issues were identified.The system appears to have been operating within specifications and functioning normally.All patient and system safety related subsystems were functional when checked by the gehc field engineer.Based on the information provided, the incident occurred due to user error of not selecting an mr safe gown for the patient scan as a primary cause and lack of padding as a secondary contributing cause.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.Additionally, patients are to be thoroughly screened for the presence of any metallic devices or objects.No further actions are planned by gehc.

• Brand Name: SIGNA PIONEER
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 11240605
• MDR Text Key: 229083432
• Report Number: 2183553-2021-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K160621
• 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: 02/05/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 72