MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA 3.0T MR750 SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Device Emits Odor (1425); Arcing (2583)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer notified ge service about a burning smell after scanning.No patient injury was reported.The rf body coil was inspected by the field engineer who found one (1) brown spot on the inside patient surface above the bridge at the side of the patient bore.This is a concern for patient warming due to long-term contact with a hot normally accessible surface.

Manufacturer Narrative

No patient involved in this event.There was no adverse event.Incident date is not known.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.

Manufacturer Narrative

H3: ge healthcare's (gehc) investigation has been completed.The body coil was visually inspected and evaluated.The eight tuning locations indicated poor soldering and insufficient cleaning after tuning at the customer site by the field engineer.With the presence of solder balls and flux residues, the board surfaces can become contaminated and cause latent defects over a period of time, potentially causing arcs in the circuit boards.No anomalies in design, manufacturing and service processes were identified.The primary root cause of the body coil issue was determined to be due to inadequate cleaning of surface contaminations at the soldering locations.

• Brand Name: SIGNA 3.0T MR750 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: 13211487
• MDR Text Key: 290910378
• Report Number: 2183553-2022-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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