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

Device Problems Unable to Obtain Readings (1516); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 12/26/2021

Event Type  Injury  

Event Description

It was reported that during an mri exam, a patient under anesthesia had an arterial cable looped on their chest.The staff became aware of a problem because the a-line pressure reading ceased.The looped cable resulted in a burn to the immediate area.

Manufacturer Narrative

Unique identifier: (b)(4).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: the investigation by ge healthcare has been completed.No systemic issues were identified in reviewing the available information.All patient and system safety related subsystems appear to have been operating within specifications and functioning normally when checked by the gehc field engineer.Although the patient was not padded per ge recommendation to prevent bore to skin and skin to skin contact and not isolated specifically from the cable involved, the improper use of the monitoring devices during the mr examination is considered the root cause of the incident after reviewing all the information.The transducer cable is not intended for use inside the bore of the mr system, and it should not be in contact with the patient and in operation or connected to a pressure monitoring system during an mr examination.Based on the above information, the root cause was determined to be inattentive or untrained/inexperienced personnel which is a user error.No further actions are planned by gehc.

• 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: 13361669
• MDR Text Key: 284508298
• Report Number: 3010949642-2022-00002
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 75 KG