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

Device Problems Use of Device Problem (1670); Device Unsafe to Use in Environment (2918); Device-Device Incompatibility (2919)

Patient Problems Bone Fracture(s) (1870); Skin Irritation (2076); Multiple Fractures (4519)

Event Date 10/18/2020

Event Type  Injury  

Manufacturer Narrative

Age: 25-30 years old.Weight: 50-55kg.Unique identifier: udi not required.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.

Event Description

It was reported that a staff member brought a ferrous oxygen tank into the scan room that became attracted to the magnet.When moving toward the magnet, the tank struck a staff member on the right side of their mid section, scratching the palm of their hand and breaking two ribs, for which she was admitted to the hospital for treatment.The patient was not injured due to this issue.The ge field engineer ramped ramped down the magnet and removed the oxygen tank from the room.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.Based on the information provided, the incident occurred due to inattentive behavior by a staff member when bringing a ferrous oxygen tank into the scan room.The mr safety guide or the operator manual with integrated safety section, which delivers to the customer, clearly defines the risks associated with owning and operating an mr scanner.It was confirmed that the ferrous object warning signs were present at the site.The gehc field engineer ramped down the magnet and safely removed the oxygen tank.No further actions are planned by gehc.

• Brand Name: GE 3.0T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10831928
• MDR Text Key: 216113663
• Report Number: 2183553-2020-00016
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other