MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

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 a patient with a history of breast cancer underwent an mri of the breast where she heard a popping sound during the examination.Due to continued pain where the popping sound occurred, the patient was seen by an orthopedic surgeon who reported multiple rib fractures.The patient was instructed to wear a corset and allow the fractures to heal.

Manufacturer Narrative

H3: the investigation by ge healthcare has been completed.There was no malfunction of the system.No trauma to the patient was reported on the day of the mr exam.The root cause of this incident appears to be prolonged contact with device or accessory creating pressure point with medium energy or force in addition to a potential underlying or pre-existing medical condition that may have contributed to the injury.Patient injuries may occur despite good clinical practices, proper patient positioning, and monitoring.No further actions are planned by gehc.

• Brand Name: DISCOVERY MR750W 3.0T
• 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: 16016823
• MDR Text Key: 305835676
• Report Number: 2183553-2022-00016
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132376
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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 Sex: Female