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

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Bone Fracture(s) (1870); Pain (1994)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

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.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a ge healthcare field engineer (fe) was servicing an mr system and brought a ferrous table motor into the scan room.While still in the field engineer's left hand, the motor was attracted to the magnet and impacted the rear of the system.The field engineer injured his hand and was diagnosed with a minor fracture to the left radial styloid in his wrist and an abrasion to his left thumb.The fe received a plaster cast as well as oral pain killers and antibiotics as treatment for the injury.

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 the ge field engineer (fe) who did not follow the steps to safely service ferrous equipment in the magnet room.The fe did not follow standard protocols and was not authorized to work independently.The fe has completed a refresher course in mr safety requirements.

• Brand Name: 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: 8718741
• MDR Text Key: 148772064
• Report Number: 2183553-2019-00012
• 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
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 07/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 70