MAUDE Adverse Event Report: GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA ARTIST; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Arcing (2583); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

No patient involved in this event.There was no adverse event.Incident date is not known.Unique identifier: (b)(6).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

The rf body coil was inspected by the ge engineering who found one 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

H3: ge healthcareâs (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 ARTIST
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road,; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer (Section G): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road,; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 13670882
• MDR Text Key: 292806673
• Report Number: 3010949642-2022-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare 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: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• 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