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

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 07/23/2018

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 a large, female patient complained of soreness of the ribs following an mri breast exam.The patient has a history of multiple rib injuries which have been reported to occur from simply bending over.The patient did report a new, anterior rib injury after the mri.The customer had ge healthcare applications review patient positioning and it was found that the site had removed coil pads when scanning to accommodate the patient's size.

Manufacturer Narrative

The investigation by ge healthcare has been completed.Based on the available information, the root cause is due to a use error.The technologist removed the breast coil pads to accommodate the patient's size.Customer did not follow ge operator manual procedures.

• Brand Name: GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 7829293
• MDR Text Key: 118652718
• Report Number: 2183553-2018-00010
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• 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: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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: 80 YR