MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT; NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Incident date is not known.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

The customer notified ge service regarding a burning smell.No injuries were reported.The ge field engineer replaced the body coil and when examined by the engineering team, a brown spot was noted on the patient surface at approximately the 3:00 bore position.This is a concern for patient warming due to long-term contact with a hot normally accessible surface.

Manufacturer Narrative

Ge healthcares (gehc) investigation has been completed.The body coil was visually inspected and evaluated.A missing solder joint at the arcing location was concluded.A solder joint connection between the rf drive cable and a rung antenna board was missed creating 1 mm gap between the rf shield and the rung causing an arc.The repair work instructions for these body coils are adequate and this body coil issue is the only event related to failure of the solder joint.A statistical approach was used and concluded with a high level of confidence that the remaining population of reworked coils in the installed base do not have the same failure mode of missing solder joints.

• Brand Name: SIGNA ARCHITECT
• 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: 15409742
• MDR Text Key: 300087597
• Report Number: 2183553-2022-00012
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K163331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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