MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

D4 unique identifier: (b)(4).D: there are no additional device identification numbers.G2 (other): voluntary medwatch #mw5115950 h3, 6: ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient became attracted to the magnet due to a metal belt that was around their waist when they entered the scan room.In addition to multiple bruises, the patient had a deep cut on their hand that required sutures.

Manufacturer Narrative

H3: ge healthcareâs (gehc) investigation has been completed.A patient was injured when a metal belt that was around their waist was attracted to the mr system.The root cause was determined to be use error.The user allowed a patient with ferrous metal on their person into the mr area, which is against the safety protocols as defined in the gehc mr safety guide, operator manual, and standard clinical practices for mr systems.Gehcâs mr safety guide or the operator manual with integrated safety section, which is delivered to the customer, clearly defines the risks associated with owning and operating an mr scanner.No further actions are planned by gehc.

• Brand Name: GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 18091400
• MDR Text Key: 327601236
• Report Number: 2183553-2023-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2004
• 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 Sex: Female