BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXPLORER

    MDR report key: 16941721 · Received May 16, 2023

    Report

    Report Number
    3010949642-2023-00004
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    June 7, 2022
    Report Date
    July 14, 2023
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED. THREE MONTHS AFTER THIS INCIDENT TOOK PLACE IN JUNE 2022, THE SYSTEM UNDERWENT AN UPGRADE IN AUGUST 2022. DUE TO THIS SYSTEM UPGRADE, ACOUSTIC TESTING COULD NOT BE COMPLETED. A REVIEW OF SERVICE RECORDS INDICATED THAT THE SYSTEM HAD A PLANNED MAINTENANCE (PM) COMPLETED IN JULY 2022, WITH NO ABNORMAL OCCURRENCES. COMPLAINTS FROM THIS SITE WERE ALSO REVIEWED AND THERE IS NO EVIDENCE OF ANY SYSTEM DEFECT RELEVANT TO THIS EVENT. THE CUSTOMER STATED THAT THEIR PROTOCOL REQUIRES SPECIFIED HEARING PROTECTION DURING THE SCAN, HOWEVER A PATIENT'S MEDICAL CONDITIONS MAY CAUSE SENSITIVITY TO ACOUSTIC LEVELS THAT OCCUR DURING NORMAL CLINICAL SCANNING. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S). AT THIS TIME, NO ADDITIONAL ACTIVITIES ARE PLANNED BY GEHC.

    Additional Manufacturer Narrative · 0

    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. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 0

    GE HEALTHCARE RECEIVED A USER REPORT STATING A PATIENT REPORTED PERMANENT TINNITUS AFTER AN MRI PERFORMED ON (B)(6) 2022. THE PATIENT WAS SEEN BY A PHYSICIAN WHO WAS UNABLE TO PRESCRIBE TREATMENT AT THE TIME DUE TO AN EXISTING CONDITION. THE PATIENT WAS SEEN AGAIN IN (B)(6) 2023 AND THERE HAD BEEN NO IMPROVEMENT. IT IS UNKNOWN AT THIS TIME IF PROPER HEARING PROTECTION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705118 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other