MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION NUCLEAR MAGNETIC RESONANCE IMAGING; SIGNA PIONEER

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Erythema (1840); Discomfort (2330)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4) 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 a mri scan, a patient sustained a rf burn to the left arm described as discomfort and reddening with one blister.The patient was initially treated with burn gel and monitored by a nurse.After 15 days, the patient returned to the doctor and was given the choice of waiting 2-3 months for the burn to heal naturally or having surgery.The patient chose surgery and has now fully recovered.The customer indicated that no padding was used to prevent patient contact with the bore wall or to prevent body looping.

Manufacturer Narrative

B4; g1, 2, 4, 7; h2, 3, 6.H3: the investigation by ge healthcare has been completed.The mr system was operating within specifications and determined to be operating normally when checked by the ge healthcare 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.

• Brand Name: NUCLEAR MAGNETIC RESONANCE IMAGING
• Type of Device: SIGNA PIONEER
• Manufacturer (Section D): GE HEALTHCARE JAPAN CORPORATION; 7-127 asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• MDR Report Key: 8210371
• MDR Text Key: 131897883
• Report Number: 9612283-2019-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K143345
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 60