MAUDE Adverse Event Report: GE MRI GE OPTIMA 450 W

Device Problems Improper or Incorrect Procedure or Method (2017); Radiofrequency Interference (RFI) (2314)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/19/2015

Event Type  Injury  

Event Description

Pt arrived to emergency room on (b)(6) 2015 at 08:44 with admission diagnosis of acute encephalopathy.Ct head with contrast was ordered and completed at 09:51 with radiologist impression stating mri would be more definitive if clinically warranted.Xr chest ordered and performed at 10:30 noting a dual-lead pacemaker.Mri brain with contrast ordered same day at 12:14 and pt was transported to department around 13:07.Pt did not feel well, was vomiting and was sent to admitted impatient room without study completed.Pt was again transported to department on (b)(6) 2015 around 18:00 and waited in mri holding for other pt to finish scan.The mri techs were working in department and finished the last outpatient scan.After outpatient schedule was completed one mri tech left for the day.The remaining mri tech verbally reviewed implants with the pt prior to scanning and he denied the presence of a pacemaker.The mri technologist then took the pt into mri zone 4 for scan.The technologist reviewed the paper mri screening form during this time which revealed the pt did have a pacemaker.She then verified the presence of the pacemaker on the pt's recent chest x-ray and immediately removed the pt from the scanner/zone 4.The pt's mri unsafe pacemaker was exposed to the magnetic field, rf and gradients for approximately 7-10 minutes.The following were immediately notified of the incident: mri lead technologist, mrsd, administrative imaging director, pt's rn.The hsrd notified the charge rn the pt's pacemaker could potentially be damaged and not function properly and recommended remote telemetry.The report was filed to the hospital's risk management department.The mrsd communicated the incident with the imaging medical director for additional communication with treating provider.The provider noted the pt was doing well without any adverse medical event.Procedures are in place for annual mri safety training however and immediate safety training facilitated by the mrsd was conducted to re-educate mri techs on policies and procedures on (b)(6) 2015.The scanning mri technologist failed to follow safe procedures prior to scanning pt due to the assumption of her fellow co-workers already screening pt.

• Brand Name: MRI GE OPTIMA 450 W
• Type of Device: MRI
• Manufacturer (Section D): GE
• MDR Report Key: 4643240
• MDR Text Key: 19344791
• Report Number: MW5041654
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 89 YR
• Patient Weight: 97