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

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that following an mr examination, a patient developed a superficial burn around the navel.At the time of the scan, there was no redness, however when the patient complained of the burning, the tech moved the patient's clasped hands away from their abdomen.The customer indicated that some padding was used, however no padding was used to prevent the hands from clasping each other or the clasped hands from resting directly on the patient's abdomen.The patient did not require any medical attention for the initial burn.It was later reported that the patient, who passed the mr screening and was wearing mr compatible clothing, sustained a 20x10cm partial thickness burn and a 5x5cm full thickness burn on her abdomen that required surgical excision of the necrotic tissue to heal.Plastic surgery was completed on day six post scan.At the time, there were early signs of infection to the burn wound and the patient was hospitalized for a week.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices were functional when checked by the gehc field engineer.The root cause of the injury was determined to be inadequate patient padding for the mri procedure.The operator documentation describes the appropriate safety measures for padding patients for mr exams.The mr operator has the final responsibility for the use and placement of non-conductive mr compatible padding and preparation of the patient, prior to starting the mr exam procedure.No further actions are planned by gehc.

• Brand Name: SIGNA EXPLORER
• 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
• MDR Report Key: 11609410
• MDR Text Key: 243615237
• Report Number: 3010949642-2021-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K143251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 45 YR
• Patient Weight: 127