MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA MR450W 1.5T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Crushing Injury (1797); No Code Available (3191)

Event Date 02/18/2019

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 while an mri technologist was transporting a patient on the system table from the prep room to the magnet room, the table was in swivel mode.As the technologist was approaching the door to the magnet room and going up a slight incline, the table started to swerve.The technologist tried to correct the table and in doing so got her right pinky finger pinched between the table and the door jam.The technologist proceeded to pull her finger out causing the tip of her finger to be pulled off.She was taken to surgery to repair the tip of her finger at which time it was also noted that she had a crushing injury to the most distal part of the phalanges.

Manufacturer Narrative

The investigation by ge healthcare has been completed.The technologist acknowledged that the table was in swivel mode, instead of steer-lock mode, while going up the incline.The table swerved as it was going up the incline.The technologist attempted to grab the table from the sides, placing her finger inside the magnet room doorway where it was pinched.The ge healthcare field engineer inspected the table for proper operation and function.The swivel casters, driving casters, and table brakes were found to be operating within specifications and functioning normally.The investigation concluded that the root cause was operator use error.The combination of not being in steer-lock mode, not controlling the table with the table transport bar, and placing her hand inside the magnet door opening led to the finger injury.No further actions are planned.

• Brand Name: OPTIMA MR450W 1.5T
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8434121
• MDR Text Key: 139251234
• Report Number: 2183553-2019-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

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: 02/28/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 61