MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA MR450W 1.5T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/24/2021

Event Type  Injury  

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.

Event Description

It was reported that while a technologist was preparing to scan a patient, she gave the patient alert bulb to the patient and moved them into the scanner.When the technologist turned to walk away from the scanner, she tripped over the remaining tubing for the patient alert that was on the floor.The technologist fell to the floor and fractured her right wrist which required surgery to repair.

Manufacturer Narrative

H3: the investigation by ge healthcare has been completed.The root cause of this incident was a use error on the part of the technologist, who did not monitor all of the lines going to the patient entering the bore during patient set-up.The technologist advanced the patient into the bore while standing between the system and the hose on the ground.The hose slack was taken up which raised the tubing off the ground and the technologist tripped on the elevated hose.The ge field engineer confirmed that the length of the patient alert hose was the correct length.The operator manual cautions the user of entanglement hazards related to any tubing, cables, or lines going to the patient traveling into the bore.The system was found to be within specification and functioning as intended.No further actions will be taken by gehc.

• Brand Name: OPTIMA MR450W 1.5T
• 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: 13549887
• MDR Text Key: 285805247
• Report Number: 2183553-2022-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160618
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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
• Patient Age: 59 YR
• Patient Sex: Female