MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC 3.0T SIGNA HDXT SIGNA VIBRANT; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

The investigation by ge healthcare has been completed and concluded that the incident occurred due to inattentive behavior of the mr technologist who allowed a patient to bring a ferrous walker into the scan room.The mr operator manual states that it is vital to have supervised and controlled access within the mr environment to keep it safe from ferromagnetic objects.The mr technologist was magnet safety trained, security zone signs were posted, and the site has a copy of the mr safety manual.The fe was able to safely remove the walker from the magnet.No further actions are planned at this time.

Event Description

It was reported that an mr technologist allowed a patient to enter the scan room with a ferrous walker.The technologist did not evaluate the walker for potentially ferrous material prior to entering the room, but intended to leave the walker a safe distance from the mr system.In the process of entering the room, the walker was attracted to the magnet and temporarily pinned the mr technologist's right hand between the walker and the magnet.The technologist was able to forcefully pull her hand out and leave the room with the patient.The technologist was evaluated in the emergency department and required two stitches for a laceration to the right hand.

• Brand Name: 3.0T SIGNA HDXT SIGNA VIBRANT
• 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: 8944786
• MDR Text Key: 155962703
• Report Number: 2183553-2019-00019
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121676
• 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
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2019
• Date Device Manufactured: 09/21/2005
• 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: 52 YR
• Patient Weight: 61