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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 06/11/2021

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.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that an anesthetized patient received a second degree burn on their thumb and first degree burns on their wrist and forefinger.It was confirmed that a non-mr safe pulse oximeter probe was attached to the patient's finger.The patient received burn treatment with ointment and has had multiple surgeries due to the wounds.

Manufacturer Narrative

H3: the investigation by ge healthcare has been completed.This hdxt system is serviced by a third party, but when the event occurred, the customer asked gehc service to review data.No systemic issues were identified in reviewing the available information, and in the absence of any conflicting information, the system appears to have been operating within specifications, and functioning normally.All patient and system safety related subsystems appear to have been operating normally when reviewed by gehc service.The root cause has been determined to be operator error of not using good clinical practices of patient screening and scanning with a non-mr safe pulse oximeter probe attached to the patient's finger.No further actions are planned by gehc.

• Brand Name: GE 3.0T SIGNA HDX MR 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: 14759207
• MDR Text Key: 294930973
• Report Number: 2183553-2022-00008
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2005
• 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): Required Intervention; Other
• Patient Age: 7 YR
• Patient Sex: Female