GE 1.5T SIGNA HDE MR SYSTEM
Received Jul 12, 2023 · Event occurred Jun 2, 2023
Report 9612283-2023-00005 · MDR key 17312499
Device
Generic name
Nuclear Magnetic Resonance Imaging
Manufacturer
Ge Healthcare Japan CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Female
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
GE HEALTHCARES INVESTIGATION HAS BEEN COMPLETED, WHICH INCLUDED A REPRODUCTION OF THE BREAST COIL SET UP WITH A SIMILAR DEVICE. THERE WAS NO DESIGN ISSUE OR MALFUNCTION IDENTIFIED FOR THE COIL OR SYSTEM. THE PATIENT DID NOT REPORT ANY PAIN OR INJURY ON THE DAY OF THE MR EXAM. BASED ON THE LIMITED INFORMATION PROVIDED, THERE IS NO OBVIOUS EVIDENCE FOR ROOT CAUSE. PATIENT INJURIES MAY OCCUR DESPITE GOOD CLINICAL PRACTICES, PROPER PATIENT POSITIONING, AND MONITORING. NO FURTHER ACTIONS ARE PLANNED BY GEHC.
Additional Manufacturer Narrative
A2: OVER 60 YEARS. A4: 50-60 KGS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WAS SCANNED ON (B)(6) 2023, WITH NO COMPLAINTS OF PAIN DURING POSITIONING, DURING SCANNING OR RIGHT AFTER THE SCAN. ON (B)(6) THE PATIENT WENT FOR A BONE EXAM AND HAD A CONFIRMED RIB FRACTURE. THERE WAS NO BONE DISPLACEMENT.