SIGNA PETMR
Received Jan 9, 2017 · Event occurred Nov 16, 2016
Report 2183553-2017-00001 · MDR key 6234046
Device
Generic name
Tomographic Imager Combining Emiss
Manufacturer
Ge Medical Systems, LlcModel number
SIGNA PETMRProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hearing Loss
- Pain
- Hearing Loss
- Pain
Narrative
Additional Manufacturer Narrative
GE HEALTHCARE¿S INVESTIGATION IN ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERGOING A PETMR EXAM COMPLAINED OF RIGHT EAR PAIN AND HEARING LOSS. THE HEARING LOSS WAS LATER CONFIRMED BY A PHYSICIAN.
Additional Manufacturer Narrative
THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED. THE SIGNA PET/MR SYSTEM LIMITS ACOUSTIC NOISE, WHEN HEARING PROTECTION IS USED. THE SYSTEM OPERATOR IS RESPONSIBLE FOR PROVIDING THE HEARING PROTECTION. IN THIS CASE, HEARING PROTECTION WAS PROVIDED AND PLACED BY THE PATIENT. THE SYSTEM ACOUSTIC LEVEL WAS TESTED TO MEET LOCAL REGULATIONS. NO SYSTEMIC ISSUE WAS FOUND. NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION.